Do not substitute parts from different clamp manufacturers. Make sure that you reassemble a clamp from only its own parts. Do not mix up parts from different clamps, even from the same manufacturer, unless the manufacturer has assured you that the parts are interchangeable. If you choose to mark clamp parts to assure that you correctly reassemble them, ask the manufacturer about the best way to do this, because some marking methods may weaken the device or compromise your ability to sterilize it. Ensure that the clamp being used is appropriate for the patient size.
Some manufacturers have two sizes of clamps, one for adults and the other for infants.
Periodically measure the gap between the device s clamping jaws to ensure that it is within the manufacturer s specification. Using a device with an inappropriate jaw gap could allow the tip of the penis to be drawn through the clamp with the foreskin and inadvertently severed or injured. We request that you follow the procedures established by your facility for such mandatory reporting. If a circumcision clamp malfunctions, you can report this directly to the manufacturer. Alternatively, you can report directly to MedWatch, the FDA's voluntary reporting program.