GEM FLOW COUPLER

Additional Manufacturer Narrative

H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURING PROCESS. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4: LOT # - THE LOT NUMBER WAS ADDED (PREVIOUSLY REPORTED AS ASKU). H6: TYPE OF INVESTIGATION - CODE B14 WAS ADDED AS A BATCH REVIEW WAS PERFORMED. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A 3.0MM FLOWCOUPLER FAILED TO HOLD THE VEIN SECURELY, REPEATEDLY SLIPPING OFF THE PRONGS. IT WAS ALSO REPORTED THAT UPON ATTEMPTING TO CLOSE THE COUPLER, THE PRONGS DID NOT ALIGN PROPERLY, PREVENTING THE COUPLER FROM CLOSING. TO RESOLVE THIS ISSUE, THE SURGEON QUICKLY OPENED ANOTHER COUPLER AND DID NOT EXPERIENCE ANY DIFFICULTIES OR ISSUES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: LOT #: THE REPORTED LOT SP24G17-2108292 IS INVALID. D4: UNIQUE IDENTIFIER (UDI) #: THE LOT # AND EXPIRATION DATE WERE NOT INCLUDED IN THE UDI # AS THE LOT WAS NOT RECOGNIZED IN THE SYSTEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.