GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI) #: THE EXPIRATION DATE (17) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01) AND LOT NUMBER (10). INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE ANASTOMOTIC INSTRUMENT OF A 1.5MM COUPLER WOULD NOT CLOSE. THE EVENT OCCURRED DURING AN ANTEROLATERAL FEMORAL FREE FLAP REPAIR AFTER ¿HANGING THE PINS¿. CLOSURE WAS SUCCESSFULLY COMPLETED BY MANUAL SUTURING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND OBSERVED THAT TWO PINS ON THE RIGHT COUPLER RING WERE BENT. THIS WOULD HINDER THE RINGS FROM BEING CLOSED AS INTENDED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.