GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, D9, H3, H4, H6 (UPDATE CODES), H11. CORRECTION: D4 UDI # (DI INFORMATION). H11: THE ACTUAL DEVICE ALONG WITH A COMPANION SAMPLE WERE RECEIVED FOR EVALUATION. BOTH DEVICES WERE ATTACHED TO AN ANASTOMOTIC INSTRUMENT AND ALL PINS WERE ABLE TO APPROPRIATELY MEET THEIR MATING HOLES ON THE OPPOSING RING; THERE WAS NO EVIDENCE OF BENT PINS. THE REPORTED CONDITION WAS NOT VERIFIED ON EITHER SAMPLE. 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.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE EXPIRATION DATE IS NOT AVAILABLE FOR THIS PRODUCT; THEREFORE, THE EXPIRATION DATE PORTION OF THE UDI WAS NOT INCLUDED IN THE MDR SUBMISSION. E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A COUPLER HAD BENT PINS. THE PROCESS STEP WAS NOT SPECIFIED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.