COUPLER

Additional Manufacturer Narrative

H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, FIVE (5) COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. THE COMPANION SAMPLE RING RETENTION TEST WAS PERFORMED (FORCE TO PULL THE COUPLER RING FROM THE JAW ASSEMBLY) AND THE RESULTS WERE WITHIN THE PRODUCT SPECIFICATION RANGE. THE REPORTED CONDITION WAS NOT VERIFIED. THE DEVICES WERE CONFORMING PRODUCTS. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A RING DISLODGED FROM A 2.5MM COUPLER. ADDITIONALLY, DURING A SURGICAL PROCEDURE "THE COUPLERS CAME OUT OF THEIR SUPPORT WHEN THE VESSELS WERE POSITIONED BY THE SURGEON". THE EVENT OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

INITIAL REPORTER LAST NAME : (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.