GEM FLOW COUPLER

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO. : (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE RING OF A 2.0MM COUPLER WAS NOT ALIGNED DURING USE IN AN INTRA-OP PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THE FLOW COUPLER RING IMPROPERLY SEATED IN THE JAW ASSEMBLY; THE FLOW COUPLER RING WAS SEATED IN AN UPSIDE-DOWN ORIENTATION MOST LIKELY BY THE USER PRIOR TO RETURNING THE PRODUCT FOR EVALUATION. IF THE RING HAD BEEN PLACED IN THE JAW ASSEMBLY IN THE ORIENTATION IN WHICH THE DEVICE WAS RETURNED, THE INSERTION OF THE PROBE WOULD NOT HAVE BEEN ABLE TO TAKE PLACE PER STANDARD MANUFACTURING PROCEDURE AND THE JAW ASSEMBLY WOULD HAVE BEEN SCRAPPED. DUE TO THE DEVICE ORIENTATION BY THE USER, THE REPORTED CONDITION COULD NOT BE VERIFIED. 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.