COUPLER

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE PIN OF TWO (2) UNSPECIFIED COUPLER PRODUCTS WAS BENT. THE ISSUE WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION B5: CORRECT PRODUCT QUANTITY TO (1) ONE (PREVIOUSLY REPORTED AS TWO). ADDITIONAL INFORMATION WAS RECEIVED FOR D1: BRAND NAME, D4: CATALOGUE #, D4: LOT #, D9, G1: DEVICE MANUFACTURER NAME, G1: DEVICE MANUFACTURER ADDRESS 1, G1: DEVICE MANUFACTURER CITY, G1: DEVICE MANUFACTURER STATE, G1: DEVICE MANUFACTURER COUNTRY, G1: DEVICE COUNTRY CODE, G1: DEVICE MANUFACTURER POSTAL CODE, G4: PMA/510K #, H3, H6, AND H10. H10: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE 1.5MM JAW ASSEMBLY WAS RETURNED IN THE WHITE PROTECTIVE HOLDER AND SHOWED SIGNS OF USE (DRIED BLOOD). A VISUAL INSPECTION OBSERVED A BENT PIN ON THE BOTTOM HALF OF THE LEFT COUPLER RING. THE REPORTED CONDITION WAS VERIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE POTENTIAL CAUSES INCLUDE THAT THE PIN COULD HAVE BEEN BENT DURING REMOVAL OF THE WHITE PROTECTIVE HOLDER, DURING PREPARATION FOR OR IN THE BEGINNING STAGES OF THE SURGICAL PROCESS WHEN THE TISSUE IS BEING EVERTED ONTO THE PINS. 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.