GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED THAT A 2.5MM COUPLER HAD A LOOSE NEEDLE. THIS WAS OBSERVED WHEN THE DEVICE WAS INSERTED INTO THE PATIENT. THE DEVICE WAS TAKEN OUT OF THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND A VISIBLE BENT PIN ON THE LEFT RING WAS OBSERVED. WHEN THE RINGS WERE BROUGHT TOGETHER, THE PINS DID NOT ALIGN WITH THE MATING HOLES DUE TO ONE PIN ON THE LEFT RING BEING SLIGHTLY BENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.