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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 WAS NOT HOLDING THE CLIP. THE PROCEDURE WAS COMPLETED... | THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP (E.G., THE INSTRUMENT PASSES ENGAGEMENT AND ABLE TO RETAIN CLIP THROUGH ENGAGEMENT BUT CANNOT APPLY THE C... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT HAD MISALIGNED JAWS. THE PROCEDURE WAS CO... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A SEVERELY BENT GRIP, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A 0.0855¿ OFFSET AT THE TIPS. THIS CAUSES THE JAWS NOT TO LINE UP. ADDITIONALLY, THE INST... |
Brand Name:NONEDevice Problem: Thermal Decomposition of DevicePatient Problem: Insufficient InformationEvent Description: A DISCREPANT PRODUCT RETURN OF A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY (TIP COVER) WAS RECEIVED BY INTUITIVE SURGICAL, INC. (ISI). THERE IS NO REPORTED ISSUE FOR THE RETURNING PRODUCT.... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY (TIP COVER) AND COMPLETED THE DEVICE EVALUATION. INSPECTION DURING FAILURE ANALYSIS IDENTIFIED LOCALIZED MELTING AT THE PROXIMAL END OF THE MCS TIP COVER.
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Brand Name:NONEDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: A DISCREPANT PRODUCT RETURN OF A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY (TIP COVER) WAS RECEIVED BY INTUITIVE SURGICAL, INC. (ISI). THERE IS NO REPORTED ISSUE FOR THE R... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY (TIP COVER) AND COMPLETED THE EVALUATION. INSPECTION DURING FAILURE ANALYSIS IDENTIFIED LOCALIZED MELTING AT THE PROXIMAL END OF THE MCS TIP COVER. |
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 CUSTOMER REPORTED THE JAWS ON THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT CLOSE ALL... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A CRACKED CLAMPING PULLEY AT THE PROXIMAL END. AS A RESULT, THE GRIP CABLE LOST TENSION. IN ADDITION, THE INSTRUMENT WAS FOUND WITH SIGNS OF CORROSION ON ... |
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 CUSTOMER REPORTED THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WOULD NOT CLOSE THE CLIP ENOUGH... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 DONOR HEPATECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT ENERGY WAS NOT WORKING. A BACKUP INSTRUMENT OF THE SAM... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END. THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE STICKING OUT FROM THE YAW PULLEY. A LOOP OF WIRE I... |
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 PROXIMAL GASTRECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER (MLCA) INSTRUMENT COULD NOT APPLY THE CLIP. THE CUSTOMER USED ... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER ... |
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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THE SYSTEM KEPT... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO BOOT UP THE SYSTEM IN NORMAL MODE WITHOUT ISSUE. THE FSE REPLACED THE LEFT MASTER TOOL MANIPULATOR (MTM) DUE TO THE RECURRING ISSUE OF ERRORS 23, 307, AND 255... |
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 SIGMOID COLECTOMY SURGICAL PROCEDURE, THERE WAS A RECOVERABLE ERROR THAT REQUESTED THE SITE TO DISABLE THE UNIVERSAL SURGICAL MAN... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR 4 (USM) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM; HOWEVER, FAILURE... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE WAS NOT ROTATING PROPERLY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND ERR... | THE CUSTOMER PERFORMED A POWER CYCLE TO RESOLVE THE ISSUE. NO SITE VISIT REQUIRED. SYSTEM WAS WORKING PROPERLY. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 30-DEGREE ENDOSCOPE FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITT... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD MISALIGNED TIPS. THE INSTRUMENT WAS LAST USED IN A RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY. THERE WAS NO ... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, AND FOUND TO HAVE A SEVERELY BENT GRIP, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A 0.2355¿ OFFSET AT THE TIPS. ADDITIONAL FINDINGS NOT RELATED TO THE REPOR... |
Brand Name:DA VINCIDevice Problem: No Display/Image; Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE INSTRUMENT HAD A FUZZY VIEW, AND THE EYES ON THE SURGEON SIDE CONSOLE ... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. |
Brand Name:ENDOWRISTDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS UNABLE TO ARTICULATE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THE REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVI... |
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 LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS NOT CLIPPING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. |
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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS HAD A WORN SHEATH WITH VISIBILITY OF LIGHT PENETRATING. THE PROCEDURE WAS COMPLETED AS ... | INTUITIVE SURGICAL, INC. (ISI) REQUESTED THE RETURN OF THE DEVICE FOR FURTHER EVALUATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.
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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 LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) SPARKED, AND THE MBF PULLEY COVER HAD THERMAL DAM... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (IS... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF FRAGM... | THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS REQUESTED TO BE RETURNED FOR EVALUATION BY THE FAILURE ANALYSIS TEAM, BUT IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONT... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT I... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER SNAPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, IN... | AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: No Device Output; Detachment of Device or Device Component; Device Dislodged or DislocatedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT HAD RECOGNITION FAIL... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND WAS ANALYZED. A REVIEW OF ERROR LOGS SHOWED 1 BLADE JAMMED ERROR MESSAGE (ERROR 22025) OCCURRING AT THE SITE ON SYSTEM SK0413 ON NOVEMBER 21, 2023. THE VESSEL SEALER INSTRUMENT FUNCTIONED PROPERLY FROM T... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER (LSND) INSTRUMENT CABLE WAS DAMAGED. THE CUSTOMER USED A BACKUP LSND... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE LARGE SUTURE CUT NEEDLE DRIVER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CABLE ON A LARGE SUTURECUT NEEDLE DRIVER (LSND) INSTRUMENT WAS BROKEN. THE CUSTOMER USED A BA... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE THE CABLE BROKEN. THERE WAS NO REPORT O... | 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 CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDE... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE WIRE BROKE ON THE MEGA SUTURECUT NEEDLE DRIVER WHILE SURGEON SUTURING. THE PROCEDURE WAS COMPLETE... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. |
Brand Name:ENDOWRISTDevice Problem: Material SeparationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL BILATERAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT JAWS WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED IN... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.184" X 0.681" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. ADDITIONALLY, THE INSTRUMENT WAS FOUND T... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, ONE SIDE OF THE YELLOW SECURING CLIP IS BROKEN OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT AND NO REPORTED INJURY. | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ANALYSIS IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE INSTRUMENT IS EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE WIRE ON THE SMALL GRASPING RETRACTOR WAS BROKEN. THERE WAS NO REPORT OF REPORTED INJURY. | 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 CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP ON THE MEGA SUTURECUT NEEDLE DRIVER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUTURECUT NEEDLE DRIVER INSTRUMENT JAW WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH A BACK... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE TENACULUM FORCEPS INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD A DAMAGED TO THE TIP AND WAS UNABLE TO FUNCTION PROPERLY. THERE WAS NO ... | AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY HOOK INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE BOTH EARS OF THE DISTAL CLEVIS BROKEN. THE BROKEN PIECES WERE N... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT'S CABLE SNAPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ... | A RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF FRAGMENT(S) FALL... | A RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH REPORTED COMPLAINT OF BROKEN CABLE. IT LOOKS LIKE... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD WIRE EXPOSED OR BROKEN AND STICKING OUT OF INSTRUMENT. THE PROCEDURE ... | INTUITIVE SURGICAL, INC. (ISI) REQUESTED THE RETURN OF THE DEVICE FOR FURTHER EVALUATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.
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Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT SCISSOR HAD A BREAK IN THE INSULATION THAT WAS NOTICED PRIOR TO ... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND THE PRIMARY FAILURE OF SCRATCHED TUBE EXTENSION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT TUBE EXTENSION EXHIBITS SIGNS OF MULTIPLE SCRA... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF FRAGM... | INTUITIVE SURGICAL, INC. (ISI) REQUESTED THE RETURN OF THE DEVICE FOR FURTHER EVALUATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE ... |
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 RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, A PIN FROM THE TIP OF THE PROGRASP FORCE... | THE INSTRUMENT HAS BEEN REQUESTED TO BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT YET BEEN RECEIVED. THE IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE REVIEWED. SINCE THE PIN WAS PUSHED BACK INTO PLACE PRIOR TO THE PHOTOS, THE FAILURE COULD NOT BE CONFIRMED THR... |
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 PROGRASP FORCEPS HAD A LOOSE JOINT AND WEAK GRIP STRENGTH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJUR... | AN INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. |
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 SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT TIP BROKE OFF. THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.66" X 0.18" WAS FOUND TO BE BROKEN OFF ... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT INSPECTION OF THE FORCE BIPOLAR INSTRUMENT IDENTIFIED THAT THE TIP WAS "CROOKED." INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER; HOWEVER, NO... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT FOR FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.185" X 0.597" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. DAMAGE TO THE INSTRUMENT CAN OCCUR WHILE PERFORMIN... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE CABLE OF THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT BROKE. THE PROCEDURE WAS COMPLETED WITH... | 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 CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MOD... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MEGA SUTURE CUT NEEDLE DRIVER WAS FOUND TO HAVE BROKEN WIRE AT WRIST. THE PROCEDURE WAS COMPLETED WITH NO REPORTED IN... | A RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. |
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 TENACULUM FORCEPS WERE UNABLE TO GRIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICA... | 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 PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SMALL GRASPING RETRACTOR HAD A FRAYED CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT AND NO REPORTED INJURY. INTUITIVE SURGICAL, ... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SMALL GRASPING RETRACTOR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS NOT INSTALLED IN THE CLEVIS. |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS USED FOR A SURGICAL TASK AND WAS OBSERVED TO HAV... | A RETURN MATERIAL AUTHORIZATION (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 DEVICE TO THE CUSTOMER REPORTED ISSUE. |
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 SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT'S PIN FELL OUT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPO... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE CABLE OF THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT TIP WAS BROKEN.... | 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 CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION... |
Brand Name:ENDOWRISTDevice Problem: Material Frayed; Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER FOUND A PIECE OF WIRE WAS BROKEN OFF FROM THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT. ... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE WAS REVIEWED BY REGULATORY POST MARKET SURVEILL... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, AS SOON AS THE CUSTOMER STARTED TO USE THE HARMONIC ACE INSTRUMENT, ONE SIDE OF THE INSTRU... | A RETURN MATERIAL AUTHORIZATION (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 CUSTOMER REPORTED ISSUE. |
Brand Name:NONEDevice Problem: Break; Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT'S GENERATOR PRESENTED A "HIGH PRESSURE AT THE TIP" MESSAGE. THIS INSTRUMENT COULD NOT W... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO FAIL INITIALIZATION WHEN CONNECTED TO THE GENERATOR. THE ERROR MESSAGE ¿REPLACE INSTRUMENT¿ KEPT APPEARING AFTER TIGHTENING THE INSTRUMENT ON THE HANDPIECE OF THE GENERATOR. S... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CABLE ON A LARGE SUTURE CUT NEEDLE DRIVER (LSND) INSTRUMENT WAS BROKEN... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE LARGE SUTURE CUT NEEDLE DRIVER. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:DAVINCI XIDevice Problem: Unintended Electrical ShockPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER FELT AN "ELECTRICAL SHOCK" WHILE PRESSING THE PATIENT SIDE CART (PSC) TOUCHPAD FOR DEPLOYMENT FOR ... | 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 EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. FSE INSPECTED THE SYSTEM FOR EXPOSED CABLES AND POTENTIAL ELECTRICAL SHORTS AND DID NOT FIND ANY ISSUES. FSE... |
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, THE TIP OF THE SUCTION IRRIGATOR DISCONNECTED FROM THE DEVICE WHEN REMOVED FROM THE TROCAR. THE FRAGMENTS FELL INTO T... | 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 CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MOD... |
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 HEPATECTOMY SURGICAL PROCEDURE, THE NURSE CALLED TO REPORT THAT THEY WERE FACING NONRECOVERABLE FAULT ON THE UNIVERSAL SURGICAL M... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND SET UP JOINT (SUJ). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUI... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE PATIENT EXPERIENCED STAPLE LINE BLEEDING DESPITE NO INTRAOPERATIVE MALFUNCTIONS. INTRAOPERATIVELY, THE SURGEON USED SEAM GUARD ON ONE S... | NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. THERE IS INSUFFICIENT PROCEDURAL INFORMATION TO PERFORM FURTHER SYSTEM AND INSTRUMENT INVESTIGATION. |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE PATIENT EXPERIENCED STAPLE LINE BLEEDING DESPITE NO INTRAOPERATIVE MALFUNCTIONS. INTRAOPERATIVELY, THE SURGEON USED SEAMGUARD ON ONE SI... | NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. THERE IS INSUFFICIENT PROCEDURAL INFORMATION TO PERFORM FURTHER SYSTEM AND INSTRUMENT INVESTIGATION. |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE PATIENT EXPERIENCED STAPLE LINE BLEEDING DESPITE NO INTRA-OPERATIVE MALFUNCTIONS. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED TO MONITOR... | NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AN ADVANCED STAPLER LOG REVIEW SHOES THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 5 TIMES AND FIRED 4 RELOADS (2 BLUE, FOLLOWED BY 2 WHITE). ON THE FIRST INSTALL, THE STAPLER FAILED TO ENGAGE WITH THE SYSTEM. SYSTEM LOGS SHOW ERROR CODE 22020,... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE STAPLE LINE OF THE FIRST BLUE SUREFORM 60 RELOAD BLED. HOWEVER, THE BLEEDING WAS DELAYED AND DID NOT BEGIN UNTIL AFTER THE SUBSEQUENT ... | NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AN ADVANCED STAPLER LOG REVIEW SHOWS THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 5 TIMES AND FIRED 5 RELOADS (2 BLUE, FOLLOWED BY 3 WHITE). ON INSTALLS 1 AND 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE COMPLETED WITH NO PAUSES FOR... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE STAPLE LINE OF THE FIRST BLUE SUREFORM 60 RELOAD BLED. HOWEVER, THE BLEEDING WAS DELAYED AND DID NOT BEGIN UNTIL AFTER THE SUBSEQUENT ... | NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AN ADVANCED STAPLER LOG REVIEW SHOWS THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 5 TIMES AND FIRED 5 RELOADS (2 BLUE, FOLLOWED BY 3 WHITE). ON INSTALLS 1 AND 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE COMPLETED WITH NO PAUSES FOR... |
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 RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, THE TIP OF THE FORCE BIPOLAR INSTRUMENT BROKE OFF AFTER COLLIDING WITH ANOTHER I... | INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED FOR RETURN OF THE FORCE BIPOLAR INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT BEEN RECEIVED. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DONOR HEPATECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOT PROPERLY ARTICULATING. THE USER COMPLETED ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN, LOOSE AND FRAYED GRIP CABLE AT THE DISTAL END. THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. FURTHER INSPECTION IDENTIFIED A FRAYED PI... |
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 SALPINGO-OOPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM DISPLAYED MULTIPLE ERROR CODE 319. THE CUSTOMER RECEIVED PHONE ASSISTANCE FRO... | 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. DURING FIELD EVALUATION, FSE CONFIRMED THE ISSUE AND REPLACED THE DISTAL AND PROXIMAL SET-UP JOINT (... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE IMAGE ROTATED 180 DEGREES. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE... | THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE TSE ADVISED THE CUSTOMER TO REMOVE THE 30-DEGREE ENDOSCOPE, TO CANCEL THE GUIDE TOOL CHANGE (GTC) AND THEN TO REINSTALL THE ENDOSCOPE. ANOTHER USER RE... |
Brand Name:DA VINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A CUSTOMER HAD A CONSTANT ERROR M-12 ON ERBE. PRIOR TO THE CALL, TECHNICAL SUPPORT HAD ALREADY REPLACED THE CAUTERY CABLES ... | 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 EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE ISI FSE REPLACED THE IESU TO RESOLVE THE ISSUE WITH ERRORS M-12. THE ISI FSE ALSO REPLACED THE BLUE FIBER KI... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT ERBE ACTIVATION WAS INTERRUPTED DUE TO ERROR C-00. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) FO... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THE ERRORS ON THE GENERATOR. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND FOUND TO ENERGIZE AND CAUTERI... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE USING A DUAL SURGEON CONSOLE SETUP, THE ENDOSCOPE ROTATED 30 DEGREES WITHOUT BEING CONTROLLED AFTE... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. DURING THE FIELD EVALUATION, THE FSE CONFIRMED THROUGH THE CUSTOMER THAT THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THE FSE REVIEWED THE PROCEDURE VIDEO AND CONFIRMED THA... |
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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE RIGHT EYE WAS OUT IN ONE OF THE SURGEON SIDE CONSOLES (SSCS). PRIOR TO ... | 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 BLUE FIBER CABLE PORT ON THE BACK PANEL OF THE SURGEON SIDE CONSOLE (SSC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMP... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT CERAMIC IN THE MOUTH AREA WAS DAMAGED BY ELECTRICITY. NO KNOWN IMPACT OR PATIENT CONS... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS UNABLE TO USE THE BIPOLAR ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE INSULATION AT THE YAW PULLEY. A VISUAL INSPECTION FOUND THE WIRE TO BE EXPOSED. THE INSTRUMENT GRIPS WERE MANUALLY MANIPULATED, A... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THERE WAS NO COAGULATION ON THE TIP OF THE MARYLAND BIPOLAR FORCEPS. THE PROCEDURE WAS COM... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHE... |
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 FORCE BIPOLAR INSTRUMENT WOULD NOT RELEASE THE SUTURE AND THE WRENCH WOULD NOT WORK. THE INSTRUMENT HAD TO BE... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FORCE BIPOLAR INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE A PERSISTENT RECOVERABLE 23094 ERROR OCCURRED. WHEN THE CUSTOMER RECOVERED THE ERROR, IT W... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE REPLACED THE USM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM FOR EVALUATION; HOWEVER, FAILURE ANALYSIS HAS NOT... |
Brand Name:ENDOWRISTDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT¿S JOINT FOLDED TO THE WRONG WAY DURING TISSUE SUTURE AND THE NEE... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER R... |
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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 STOPPED PERFORMING. THE CUSTOMER WAS UNABLE TO GET THE USM ... | 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 EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE C... |
Brand Name:SUREFORMDevice 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 SURE FORM 45 STAPLER WOULD NOT RELEASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER R... |
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 HAD A BENT TIP AND WOULD NOT HOLD CLIPS. THE PROCEDURE WAS COMPLETE... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER R... |
Brand Name:DA VINCI ENERGYDevice Problem: Difficult to Open or ClosePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT OUT OF BOX, THERE WAS AN AUDIBLE POP HEARD AND A COMPONENT WITHIN THE SHEATH OF THE SYNCHROSEAL WAS VISIBLY BROKEN PRIOR TO USE. THE JAWS WOULD NOT OPEN OR CLOSE. THE PROC... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED GRIP RING AT THE PROXIMAL END. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND EXHIBITED IMPRECISE MOTION. THE GRIP TIPS WERE UNABLE TO BE FULLY... |
Brand Name:DAVINCI XIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, ALL OF THE ARMS MOVED A LITTLE WHEN THE CANNULAS WERE INSTALLED, AND THE INSTRUMENTS WERE IN THE PATIENT. THERE WE... | AN INTUITIVE FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER AND CONFIRMED THAT THE ISSUE DID NOT RETURN AND CONFIRMED ARM MOVEMENT WAS NORMAL. THE COMPLAINT WAS NOT CONFIRMED BY THE FSE INVESTIGATION. |
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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, ONE OF THE SURGEON'S SIDE CONSOLES (SSC) HAD A TOUCHPAD THAT WAS NOT TURNING ON. THE INTUI... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE WENT ON SITE AND WAS NOT ABLE TO REPLICATE THE ISSUE BUT REPLACED THE TOUCH SCREEN AS A PRECAUTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATE... |
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 THAT SEVERAL NON-RECOVERABLE FAULTS OCCURRED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE PROXIMAL SET-UP JOINT (SUJ), DISTAL SUJ, AND THE FIBER CABLES TO ADDRESS THE ISSUE. THE FIBER CABLES ARE FIELD SCRAP ITEMS AND WILL NOT BE RETURNED BACK TO ISI. ISI HAS RECEIVED BOTH THE PROXIMAL SUJ AND DIST... |
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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT CLIPPING. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTE... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). THE REPORTED ISSUE WAS CONFIRMED. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE A SEVERELY BENT GRIP TIP. THE DAMAGE WAS FOUND NEAR THE TOP OF THE CLIP GROOVE, CAUSING AN OFFSET AT THE TIPS... |
Brand Name:DAVINCI XIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE CUSTOMER ENCOUNTERED AN ERROR THE BED WAS UNPAIRED, AND THE INSTRUMENT TIPS MOVED ON THEIR OWN IN THE PATIENT'S... | AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO INVESTIGATE THE REPORTED ISSUE. THE ISI FSE FOUND NO ISSUES WITH THE SYSTEM BUT DID PROACTIVELY REPLACE THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (I... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD BLADE EXPOSURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPO... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND/OR LOCALIZED MELTING ON THE OUTER SURFACE OF ONE BIPOLAR YAW PULLEY, RESULTING IN AN EXPOSED ELECTRODE. THE INSTRUMENT WAS PLACED AND DRIVEN O... |
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, A LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS NOT CLIPPING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOWUP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 PRONGS WERE BENT ON THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT AND THE CLIPS WERE NOT CLOSING PROPERLY. THE PRO... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BENT GRIP TO BE RELATED TO THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BE GRIP AND THE TIP DOES NOT ALIGN WITH THE OTHER GRIP. THE ... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - SIMPLE SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD NO HIGH FREQUENCY . THE PROCEDURE WAS COMPLET... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE PROXIMAL END. THE LOCATION OF THE BREAK IS NEARBY THE BIPOLAR PIN JUNCTION. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TES... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS HAD A BROKEN WIRE AT THE WRIST. THE PROCEDURE WAS COMPLETED WITH NO REPORTED IN... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED. VISUAL INSPECTION FOUND NO DAMAGE TO THE INSTRUMENT'S CABLE. NO PRODUCT ISSUE WAS IDENTIFIED. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. ADDITIONALLY, THE INSTRUMENT... |
Brand Name:ENDOWRISTDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT TURNING AND ROTATING WELL. THE PROCEDURE WAS COM... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE FORCE BIPOLAR INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT AND NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWE... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.185" X 0.653" WAS FOUND TO BE BROKEN OFF THE YAW PULLEY. THE BROKEN PIECE WAS RETURNED AND IS STILL ATTACHED TO T... |
Brand Name:NONEDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: THE SP INSTRUMENT SHEATH WAS AN INCIDENTAL RETURN INCLUDED WITH THE FENESTRATED BIPOLAR FORCEPS WHICH ALLEGES THAT AN INSTRUMENT SHEATH WOULD NOT GO ON, AND ANOTHER WAS FOUND WITH A LOOSE RU... | FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF DISLODGED COEXTRUSION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE COEXTRUSION COMPONENT WAS FOUND TO BE DISLODGED AT THE DISTAL TIP. THE COEXTRUSION WAS EASILY REMOVED FROM THE SHEATH. THERE WAS NO MISSING MATERIAL. A SECOND SP INSTRUMENT SHEATH ACCESSORY WAS ANAL... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS HAD A BROKEN DISTAL TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR NO REPORTED INJURY. | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER HAD A "POP" NOISE AND A CABLE WAS NOTED TO BE LOOSE. THE PROCEDURE WAS COMPLETED WIT... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER STATED THE ROPE BROKE ON THE LARGE SUTURECUT NEEDLE DRIVER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, ... | 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 CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MOD... |
Brand Name:DA VINCIDevice Problem: 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 UNIVERAL SEAL BROKE OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SEAL ACCESSORY WAS ANALYZED AND FOUND TO FOUND TO HAVE A BROKEN LUER FITTING. ONLY THE LUE FITTING OF THE SEAL WAS RETURNED. THE PIECE MEASURES APPROXIMATELY 0.232" X 0.434" IN SIZE. THE COMPLAINT WAS CONFIRMED BY F... |
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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, WHEN THE BIPOLAR ENERGY WAS ACTIVATED, THE SYSTEM EMITTED AUDIBLE FEEDBACK, BUT... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE. A PIECE MEASURING PROXIMATELY 0.028¿ X 0.028¿ AND 0.018" X 0.075" WAS NOT RETURNED WITH THE INSTRUMENT. VISUAL INSPECTION WAS PERFORMED AN... |
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 VESSEL SEALER EXTEND (VSE) HAD A CABLE BREAK WHILE BEING USED TO CUT TISSUE. NO PIECES WERE L... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. ADVANCED TECHNICAL REVIEW (RESULTS): A REVIEW OF THE LOGS FOR THE VSE ASSOCIATED WITH THIS EVENT HAS BEEN PERF... |
Brand Name:ENDOWRIST SPDevice Problem: Detachment of Device or Device Component; Material Twisted/BentPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND THE REPORTED FAILURE WAS REPLICATED AND CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE A BENT LOWER GRIP, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE ... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR WRIST SNAPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF T... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, THE WIRES BROKE ON THE MEGA SUTURECUT NEEDLE DRIVER WHEN GRIPPING A NEEDLE. THE PROC... | 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 CUSTOMER REPORTED ISSUE. |
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