GEM FLOW COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, H4, H6, 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.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A 3.0MM FLOW COUPLER WAS NOT CLOSING ALL THE WAY EVEN WHEN THE DEVICE WAS CLOSED ALL THE WAY. THE SPIKES COULD BE SEEN JUST STARTING TO PENETRATE THE OTHER SIDE; HOWEVER, IT WAS NOT NEAR TO WHERE IT NORMALLY SHOULD BE. THE ISSUE OCCURRED DURING AN INTRA-OPERATION STEP. WHEN SQUEEZING THE FLOW COUPLER, THE DEVICE WOULD NOT COMPLETELY CLOSE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.