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Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THERE WERE ERRORS C-30 ON THE ERBE GENERATOR DURING MONOPOLAR ENERGY ACTIVATION. THE TECHNICAL SUPPORT E... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTRO SURG... |
Brand Name:DA VINCI ENERGYDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE WHITE TIP INSIDE OF THE JAW OF THE SYNCHROSEAL CAME OFF DURING T... | INTUITIVE HAS RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT THE WHITE TIP INSIDE THE JAW CAME OFF DURING PROCEDURE. THE CUT ELECTRODE WAS OBSERVED TO BE PARTIALLY LIFTED FROM ... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND THAT THE MONOPOLAR CURVED SCISSORS (MCS) HAD A BURNT SHAFT CLOSE TO TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MONOPOLAR CURVED SCISSORS (MCS) HAD A BURNT SHAFT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MCS WAS ANALYZED AND FOUND TO ... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT AN ERROR T... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED THE REPORTED ISSUE AND REMOVED AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (U... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE CLIP DID NOT CLOSE USING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIP CLOSURE ISSUE, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLO... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJUR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY HOOK INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BR... |
Brand Name:ENDOWRISTDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS NOT ACTIVATING THE COAGULATION AS IT HAD ELE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MBF WAS NOT CAUTERIZING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO FAILURE ANALYSIS I... |
Brand Name:NONEDevice Problem: No Device Output; Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE RECOGNIZED. THE PROCEDURE WAS COMPLETED USING... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVE THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A PARTIALLY MI... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HOOK ON THE PERMANENT CAUTERY HOOK BROKE IN THE MIDDLE OF THE OPERATION FOR NO ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN HOOK. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE C... |
Brand Name:DAVINCI XDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A CUSTOMER GOT A RECOVERABLE ERROR 23087 ON ARM1. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A RECOVERABLE FAULT ON THE UNIVERSAL SURGICAL MANIPULATOR 1 (USM). AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE USM TO RESOLVE THE ISSUE. AN RMA WA... |
Brand Name:ENDOWRISTDevice Problem: Firing ProblemPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, WHILE USING AN ENDOWRIST 30 CURVED-TIP STAPLER INSTRUMENT WITH A WHITE STAPLER 30 RELOAD ON A VESSEL, THE SURGEON EXPERIENCED A PARTIAL FIRE... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PARTIAL FIRE IS UNKNOWN. THE PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE LOGS SHOW AN ENDOWRIST 30 CURVED-TIP STAPLER INSTRUMENT WAS IN... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON DID NOT HAVE APPROPRIATE CONTROL OF INSTRUMENT. THE INSTRUMENT WAS MOVING IN THE OPPOSITE DIR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNINTUITIVE MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER WAS ANALYZED, AND THE REPORTED FAILURE WAS NOT CON... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE ENDOSCOPE PICTURE WAS UPSIDE DOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PICTURE WAS UPSIDE DOWN, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. ISI HAS RECEIVED THE ENDOSCOPE INVOLVED... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA TAPP SURGICAL PROCEDURE THE MEDIUM-LARGE CLIP APPLIER DID NOT CLAMP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER WOULD NOT CLAMP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER WAS ANALYZED... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THERE WAS NON-INTUITIVE MOTION ON THE SYSTEM. THE CUSTOMER EXPERIENCED NON-INTUITIVE MOTION ON ALL F... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION ON ALL FOUR USMS OF THE PSC, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GAT... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) KEPT RESETTING AND KEPT FAULTING. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING KEPT FAULTING, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE ERB... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT STARTED CLIPPING THEN BROKE AND WOULD NOT CLIP. THE P... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT CLIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. ... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPARKED, AND THE INSTRUMENT EDGE TURN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ARCED AND THE INSTRUMENT EDGE TURNED BLACK, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. TH... |
Brand Name:SINGLE-SITEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE WRIST OF A SINGLE-SITE WRISTED NEEDLE DRIVER INSTRUMENT MOVED IN THE OPPOSITE DIRECTIO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT MOVED WITH UNINTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE-SITE WRISTED NEEDLE DRIVER WAS A... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT'S CABLE WAS CUT. A BACKUP INSTRUMENT OF THE SAME KIND ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN INSTRUMENT BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND WAS FOUND T... |
Brand Name:SINGLE-SITEDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A CADIERE FORCEPS INSTRUMENT HAD A WARPED SHAFT. THE CUSTOMER WAS UNABLE TO REMOVE IT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CADIERE FORCEPS INSTRUMENT HAD A WARPED SHAFT AND WAS UNABLE TO REMOVE FROM CANNULA, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE, BUT THE PRODUCT H... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING THAT THE INSTRUMENT'S JAW BROKE OFF DURING DECONTAMINATION PROCESS. NO FRAGMENTS FELL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING JAW BROKE OFF, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE... |
Brand Name:DAVINCI XIDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT COULD NOT FIRE AS USUAL, STAPLED ONLY HALFWAY... | BASED ON THE CLAIMS AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ABORTED PROCEDURE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER-REPORTED ISSUE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED... |
Brand Name:ENDOWRISTDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) HAS MADE AN ATTEMPT TO OBTAIN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN UNKNOWN ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HA... |
Brand Name:DAVINCI XIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM) WAS NOT RECOGNIZING INSTRUMENTS. THE SITE RESEATED THE DRAPE, A... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT USM 3 WAS NOT RECOGNIZING INSTRUMENTS, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON SITE, REPRODUCED THE REPORTED FAILURE, AND REPLACED THE UNIVERSAL SURGICAL MANIPULATO... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THAT RECOVERABLE ERRORS OCCURRED. THE SITE RESTARTED THE SYSTEM WITH NO CHANGE. THE INTUITIVE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A RECOVERABLE FAULT OCCURRED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MONOPOLAR HOOK WHICH WAS BEING USED BY THE SURGEON DISENGAGED ITSELF FROM THE INSTRUMENT ARM AND THEREFORE MOVED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNINTENDED MOTION OF PERMANENT CAUTERY HOOK, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CUSTOMER REENGAGED THE INSTRUMENT TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF ... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND S... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE RECOVERABLE FAULT ON THE SYSTEM. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE DISCOVERED THAT THE PATIENT SIDE CART (PSC) CONFIGURED ON SYSTEM SK2434 THAT... |
Brand Name:SINGLE-SITEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT WAS NOT ROTATED. A BACKUP INSTRUMENT OF SAME TYPE WAS USED TO... | THE WRISTED NEEDLE DRIVER INSTRUMENT HAS BEEN FURTHER EVALUATED BY THE ADVANCED FAILURE ANALYSIS AND THE INITIAL FAILURE ANALYSIS RESULTS WERE CONFIRMED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND CONFIRMED TO EXHIBIT UNINTUITIVE MOTION. IT WAS OBSERVED THAT WHEN ATTEMPTING TO EXECUTE THE ROLL MOTION, THE WRIS... |
Brand Name:DAVINCI XIDevice Problem: Activation, Positioning or Separation ProblemPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY... | BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO THE NUMEROUS MESSAGES RELATED TO THE TABLE MOTION. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE FOUND NO ERROR LO... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT MOVED WITH NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENT HAD NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL RECTOPEXY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THAT PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY. TECH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RUNNING ON BATTERY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE P... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT HAD SPARKS APPEAR AND BLACK SMOKE WAS EMITTED. THE PROCEDURE WAS COMPLETED USING A BACKUP PERMA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARCING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFI... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, THE TISSUE WAS STICKING TO THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WHILE THE SURGEON WAS ... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING THE TISSUE WAS STICKING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF TH... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THE INSTRUMENTS WERE MOVING... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNINTUITIVE MOTION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE TECHNICAL SERVICE ENGINEER (TSE) ASSISTED THE CUSTOMER THROUGH REMOVING THE ENDOSCOPE AND PRESSIN... |
Brand Name:DAVINCI XIDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE HORIZON ON THE ENDOSCOPE WAS SPINNING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER PLACED THE ENDOSCOPE ON A DIFFERENT ARM AND THE SPINNING STOPPED. THE C... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE USER OBSERVED THAT THE PIN WAS LOOSE FROM THE DISTAL END OF THE LARGE SUTURECUT NEEDLE DRIVER ... | ADDITIONAL ANALYSIS WAS PERFORMED ON THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT BY A FAILURE ANALYSIS ENGINEER. THE CLEVIS PIN WAS CONFIRMED TO BE DISLODGED. THE CLEVIS PIN APPEARED TO HAVE BEEN OVER SWAGED. Manufacturer Narrative: BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A LOOSE PIN, AN INVESTIG... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT HAD A NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETED WITH NO R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-INTUITIVE MOTION, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT MOVED WITH NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENT HAD A NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZ... |
Brand Name:ENDOWRISTDevice Problem: Difficult or Delayed ActivationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAD INCOMPLETE SEALING. THE PROCEDURE WAS COMPLETE WITH NO REPORTE... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING INSUFFICIENT SEALING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE D... |
Brand Name:ENDOWRISTDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS NOT SEALING WELL. THERE WAS ALSO AN EXPOSED WIRE AT THE TIP. THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS NOT SEALING WELL. AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT FOR A FAILURE ANALYSIS. HOWEVER, THE INVESTIGATION IS NOT YET C... |
Brand Name:DAVINCI SIDevice Problem: MisfocusingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE CAMERA WAS UNABLE TO FOCUS. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN IMAGE FOCUSING ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFI... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A CHIP ON THE WHITE PLASTIC PART OF THE TIP. THERE WAS NO REPORT OF PATIENT INVOLVEME... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A CHIP ON THE WHITE PLASTIC PART OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FBF I... |
Brand Name:NONEDevice Problem: Material SeparationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP WAS SEPARATED FROM THE MCS INSTRUMENT AND FELL INTO THE PATIENT¿S ANATOMY. INTUITIVE SURG... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MONOPOLAR CURVED SCISSORS (MCS) TIP WAS SEPARATED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVIC... |
Brand Name:SUREFORMDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL SLEEVE GASTRECTOMY PROCEDURE, CUSTOMER REPORTS, AS THE STAPLER WAS FIRING, IT STOPPED MIDWAY AND TRIED TO COMPRESS THE TISSUE. TH... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING AS THE STAPLER WAS FIRING, IT STOPPED MIDWAY AND TRIED TO COMPRESS THE TISSUE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION... |
Brand Name:DA VINCI ENERGYDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF THE SHAFT PROTECTIVE COVERING ON THE SYNCROSEAL INSTRUMENT BROKE AND FELL INTO THE PATIENT. THEY WER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A FRAGMENT FELL INTO A PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCROSEAL INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILUR... |
Brand Name:DAVINCI XIDevice Problem: Insufficient InformationPatient Problem: Insufficient Information; Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not AvailableEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED ROUX-EN-Y PROCEDURE ON (B)(6) 2023, THE PATIENT EXPIRED. THROUGH FOLLOW UP W... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF DEATH IS UNKNOWN. NO PRODUCT HAS BEEN IMPLICATED OR RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. REVIEW OF THE PROCEDURE INSTRUMENT LOG FILES SHOW A SUREFORM 60 INSTRUMENT WAS INSTALLED ON THE SYSTEM 7 TIMES AND FIRED 6 RELOADS (6 WHITE). ON INSTALLA... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT EXHIBITED NON-INTUITIVE MOVEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE PERMANENT CAUTERY HOOK INSTRUMENT HAD NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE ERRORS DISPLAYED ON THE ERBE GENERATOR. THE BIOMED CALLED IN TO REPORT THE ISSUE AFTER THE CASE FROM OUTSIDE OF T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERRORS ON THE ERBE GENERATOR, AN INVESTIGATION IS IN PROGRESS. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ERBE WAS REPLACED PER PROCEDURE. THE SYSTEM WAS T... |
Brand Name:DAVINCI SIDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT PRIOR TO THE START BUT AFTER PORT PLACEMENT OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE APPLICATION OF GAS INTO THE PATIENT¿S ABDOMEN FOR PNEUMOPERITONEUM WAS START... | ALTHOUGH THERE IS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE INCIDENT. BASED ON THE INVESTIGATION, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE INCIDENT. WHILE THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SY... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In Patient; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS USED FOR APPROXIMATELY 30 MINUTES AND FOLLOWING... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN BLADE... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE PERMANENT CAUTERY HOOK (PCH) HAD PHYSICAL DAMAGE. THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE ON THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PCH TO PERFORM FAILURE ANALYSIS. THE PCH WAS ANALYZED AND FOUN... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Foreign Body In Patient; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY - PEDIATRIC SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT MISFIRED. THE IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MISFIRED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS... |
Brand Name:DAVINCI SIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, ERROR 25596 CONCERNING ARM1 WAS RECEIVED. PRIOR TO CALL, THE SITE ALREADY REPLACED THE STERILE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 25595 ON ARM 1, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE INVESTIGATION TO DETERMINE THE CAUSE... |
Brand Name:DAVINCI SIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM GAVE ERROR 23021. THE TECHNICAL SERVICE ENGINEER (TSE) TSE CHECKED THE LOGS AN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE CUSTOMER ABANDONED THE ARM AND CONTINUED THE CASE AS A THREE ARM SYSTEM. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ISSUE. INTUITIVE... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN REINFLATING THE LUNG AFTER USING THE SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT, LEAKS WERE NOTED. PER A NURSE FROM THE SITE WHO ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS AND THE DEVICE LOGS FOR A ... |
Brand Name:DAVINCI XIDevice Problem: Poor Quality ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL INGUINAL HERNIA BILATERAL SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN SSC HRSV ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD ... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLIP WAS NOT TRIGGERED PROPERLY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A CLIP-TRIGGERING ISSUE, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DEVICE RETURNED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER-REPORTED ISSUE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREF... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHILE CHANGING THE LARGE NEEDLE DRIVER INSTRUMENT, WITH THE SURGEON¿S HANDS OUT OF CONTROLLERS, THE RIGHT-HAND CONT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON INTUITIVE MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS REPORTABLE MALFUNCTION... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE SUREFORM 60 STAPLER RELOAD WAS UNABLE TO STAPLE. THE ISSUE OCCURRED DURING ANASTOMOSIS WHILE USING A SUREFORM 60 STAPLER INS... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE DEVICE INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. REVIEW OF THE SYSTEM LOG WAS COMPLETED, AND NO RELA... |
Brand Name:DAVINCI XIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THERE WAS NO RESPONSE OF THE DISKS AFTER THE CUSTOMER ENGAGED THE STERILE AD... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RECOGNITION ISSUE, AN INVESTIGATION WAS COMPLETED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE STERILE ADAPTER (SA) WAS NOT ENGAGED ON THE UNIVERSAL SURGICA... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING CENTRAL PROCESSING, THAT A PROGRASP FORCEPS INSTRUMENT WAS NOTED TO HAVE A LOOSE SCREW. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, NOTING A PROGRASP FORCEPS INSTRUMENT HAD A LOOSE SCREW. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROGRASP FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVAL... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Perforation of EsophagusEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE PATIENT HAD A THORACOTOMY THE NEXT DAY TO REPAIR TO REPAIR A HOLE IN THE ESOPH... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCTS ARE EXPECTED FOR RETURN TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONA... |
Brand Name:NONEDevice Problem: Material Split, Cut or TornPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY WAS RETURNED WITHOUT ANY ALLEGATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS ACCESSORY. ALTHOUGH THERE WAS NO CLAIM AGAINST THE PRODUCT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE RMA. THE TIP COVER WAS FOUND TO HAVE TEARING AT T... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY, THE TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED REGARDING A ERROR C-00 ON THE INTEGRATED ELECTROS... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO THE C-00 ERROR. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE INVESTIGATIO... |
Brand Name:NONEDevice Problem: Unintended System Motion; Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE ROTATION ASSEMBLY WAS STIFF. THE CAMERA WOULD PARTIALLY ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ROTATION ISSUE. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO TH... |
Brand Name:DAVINCI XIDevice Problem: Grounding MalfunctionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE GROUNDING PAD INDICATOR WOULD NOT TURN GREEN. PRIOR TO CALLING, THE CUSTOMER HAD TRIED FOUR D... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING GROUND PAD INDICATOR WOULD NOT TURN GREEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EV... |
Brand Name:DA VINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERRORS C-34 ON VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU), AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED... |
Brand Name:SUREFORMDevice Problem: Failure to CutPatient Problem: Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not AvailableEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, WHILE STAPLING GASTRIC TISSUE, THE SUREFORM 60 STAPLER INSTRUMENT WOULD NOT COMPLET... | BASED ON THE CUSTOMER'S CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PRODUCT FOR EVALUATION. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM LOGS FOR THE EVEN... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PLASTIC PART OF THE JOINT WAS BROKEN OFF ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYS... |
Brand Name:NONEDevice Problem: No Display/ImagePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE HAD A VIDEO LOSS ERROR CODE. THE ENDOSCOPE WAS HOT AS WELL. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING VIDEO POWER LOSS, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED 30-DEGREE ENDOSCOPE TO PERFORM FAILURE ANALYSIS; HOWEVER, FAILURE ANALYSIS IS NOT COMPLETED. A SUPPLEMENTAL MDR WILL BE S... |
Brand Name:NONEDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THAT THE MONOPOLAR CURVED SCISSORS (MCS) GRAY PROTECTIVE SHEATH WAS TORN AND THE ORANGE LAYER WAS SHOWI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A DAMAGED MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETER... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WILL NOT CLIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADD... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER WAS ANALYZED AND FOUND WITH MULTIPLE BROKEN INPUT DISKS. INPUT DISK #7 WAS FOUND COMPLETELY DETACHED FROM THE BASE OF THE HOUSING. HAIRLINE CRACKS WERE FOUND ON GRIP INPUT SHAFT #6. COMMON CAUSES OF T... |
Brand Name:SINGLE-SITEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT WAS NOT ROTATED. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE WRISTED NEEDLE DRIVER INSTRUMENT DID NOT ROTATE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE WRISTED NEEDLE DRIVER INSTRUMENT... |
Brand Name:DAVINCI XIDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING VISION LOSS IN RIGHT EYE OF SURGEON SIDE CONSOLE (SSC), AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE TH... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE, THERE WAS NON INTUITIVE MOTION ON ALL OF THE 4 ARMS. THE CUSTOMER REMOVED AND RE-INSTALLED SCOPES AND... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30 DEGREE ENDOSCOPE TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE CAMERA ADAPTER BINDING/FRICTION ISSUE AND DESICCANT CONTAINER DAMAGE OR LOOSE DESICCANT BALLS. THE COMPLAINT REGARDING NON-INTUITIVE MOTION WAS CONFIRMED BY FAILURE ANALYSIS, WHICH I... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED THE INTUITIVE SURGICAL INC.(ISI) TECHNICAL SERVICE ENGINEER (TSE) REGARDING AN ONGOING ERBE E... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SYSTEM INCOMPATIBILITY ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE ORIENTATION ON THE ENDOSCOPE WAS OPPOSITE, RIGHT WAS LEFT, LEFT WAS RIGHT, UP IS DOWN AND ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNEXPECTED MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED TH... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; CorrodedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATION BIPOLAR FORCEPS INSTRUMENT HAD DARKENED CHIP IN THE INNER SIDE OF THE HOUSING ON THE DISTAL END BY TH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DARKENED CHIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE FENESTRATION BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FAILURE AN... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE PATIENT'S MEDICAL HISTORY INCLUDES... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. A REVIEW OF THE BRIEF CASE VIDEO... |
Brand Name:DA VINCI SPDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Burn(s); SeromaEvent Description: ON 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE MENTIONED BURN AND POST-OPERATIVE REDNESS AND HEATING SENSATION CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP M... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS INITIALLY REPORTED, THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS INSPECTED, AND CUSTOMER IDENTIFIED BURNT RESIN OR THERMAL DAMAGE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE... | BASED ON THE CLAIM AGAINST THE PRODUCT, BY THE CUSTOMER NOTING INSTRUMENT ARCING. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER, REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. ISI HAS NOT RECEIVED THE PRODUCT INVOLVED W... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING AND/OR AFTER A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, A PATIENT EXPERIENCED SERIOUS COMPLICATIONS, INCLUDING A BRONCHOPLEURAL (BP) FISTULA AND MULTIPLE OPERATIONS, ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE COMPLICATIONS CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE ADVANCED INSTRUMENT LOG FOR THIS INSTRUMENT WAS PERFORMED BY AN INTUITIVE SURGIC... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF THE YELLOW PART OF THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT BROKE OFF INSIDE OF THE PATIENT. THE FRAGME... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT BROKE OFF INSIDE THE PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION... |
Brand Name:NONEDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE OUTER LENS OF THE 30-DEGREE ENDOSCOPE WAS MISSING. THERE WAS NO REPORT OF INJURY. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A MISSING OUTER LENS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA HAD BEEN ISSUED REQUESTING ... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT FAILED TO ENGAGE. A BACKUP INSTRUMENT OF SAME KIND WAS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ENGAGEMENT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO FAIL MECHANI... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A BROKEN CABLE. A BACKUP INSTRUMENT OF THE SAME KI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN ... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CONDUCTOR WIRE INSULATION OF THE FENESTRATED BIPOLAR FORCEPS (FBF) WAS SCRATCHED. THERE WAS NO REPORTED INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE CONDUCTOR WIRE INSULATION OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS SCRATCHED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FBF INSTRUMENT HAS NOT YET BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SUBTOTAL SURGICAL PROCEDURE, THE MEDIUM LARGE CLIP APPLIER INSTRUMENT DID NOT ALLOW TO CLOSE TWO CLIPS CONSECUTIVELY. THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIP APPLICATION ISSUE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THE REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. ISI HAS NOT RECEIVED THE PRODUCT INVOLVED... |
Brand Name:DA VINCI ENERGYDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, A FRAGMENT FELL FROM THE SYNCHROSEAL INSTRUMENT INTO THE PATIENT. DURING INTRAOPER... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA) INVESTIGATION. FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED WASHER AT THE DISTAL END. THE DISLODGED WASHER WAS RETURNED WITH THE INSTRUMENT. THERE ... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED AN IS... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED AN ERROR OF 23069. THE UNIT WAS TESTED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND FAILED INS... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE CUSTOMER HAD TO INCREASE THE ENERGY LEVEL DUE TO THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S ENERGY OUTPUT WAS WEAK, AND THE INSTRUMENT'S WIRE WAS COMPLETELY DISCONNECTED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FEN... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT SECURE THE CLIP ON THE VESSELS. THE PROCEDURE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT SECURE THE CLIP ON THE VESSELS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI MEDIUM-LARGE CLIP APPLIER INSTRUMENT TO PER... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: HematomaEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, A PERMANENT CAUTERY HOOK (PCH) WAS USED TO DISSECT THE PELVIC LYMPH NODES AND THE INSTRUMENT ARCED FROM THE AMBER AREA. THE INSTRUMENT DID NOT C... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT ARCED, AN INVESTIGATION WAS CONDUCTED. INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS (FA) INVESTIGATIONS WERE COMPLETED, AND FA REPLICATED AND CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. FA FOUND THE PRIMARY ... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED. THERE WAS NO REPORTED PATIENT IMPACT OR HARM. INTUITIVE SURGICAL,... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER FAILED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI HAS RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. THEREFORE, THE RO... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, AFTER CLAMPING THE VENA CAVA AND THE RENAL VEIN AND STARTING THE TUMOR EXCISION, THE SURGEON EN... | THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED TO INTUITIVE SURGICAL, INC, (ISI) BY THE SURGEON: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE PATIENT'S ANATOMY; THIS WAS ANTICIPATED AS A POSSIBILITY PRIOR TO THE SURGERY. ABOUT 2.25 HOURS INTO THE SURGERY, THE SURGEON WAS DISSECTING THE VENA CAVA FOR A THRO... |
Brand Name:ENDOWRISTDevice Problem: MisfirePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE ENDOWRIST 30 CURVED-TIP STAPLER INSTRUMENT MADE A GRINDING NOISE; HOWEVER, THE SURGEON CONTINUED TO FIRE ON THE PULMONARY ARTERY WITH ... | BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS, THE PROBABLE CAUSE OF THE REPORTED INCIDENT COULD BE USER RELATED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE RELOAD FOR EVALUATION. THE RELOAD WAS FOUND TO HAVE THE KNIFE EXPOSED WITHIN TH... |
Brand Name:ENDOWRISTDevice Problem: Defective DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP HAD A PIECE OF DAMAGED PLASTIC. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS WAS ANALYZED AND FOUND TO FAILURE ANALYSIS INVESTIGATIONS REPLI... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED THORA VENT PLACEMENT. THE PATIENT WAS DISCHARGED HOME AFTER THE PROC... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. PER AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAIL... |
Brand Name:DAVINCI XIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LAPAROSCOPIC RADICAL PROSTATOVESICULECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED THAT THE MASTER TOOL MANIPULATOR (MTML) WAS NOT RESPON... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MASTER TOOL MANIPULATOR (MTM) NOT RESPONSIVE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPO... |
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