COUPLER

Additional Manufacturer Narrative

H10: THE DEVICE WAS RECEIVED FOR EVALUATION WITH SIGNS OF DRIED BLOOD WHICH IS CONSISTENT WITH THE REPORT THAT THE ISSUE OCCURRED DURING USE. DURING VISUAL INSPECTION DAMAGE (GOUGES) TO THE LEFT RING WAS OBSERVED. THE DAMAGE APPEARED TO BE CAUSED BY A MICROSURGICAL INSTRUMENT DURING THE SURGICAL PROCEDURE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.

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 STEEL NEEDLE (PIN) OF A 1.5MM COUPLER WAS FOUND BENT. THIS WAS IDENTIFIED DURING A DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) FLAP PROCEDURE. WHEN PERFORMING THE ANASTOMOSIS BETWEEN THE INFERIOR EPIGASTRIC VEIN AND THE INTERNAL THORACIC VEIN THE STEEL NEEDLE ON ONE SIDE OF THE ANASTOMOTIC RING WAS BENT AND THE SPRING OF THE STAPLER BASE WAS JAMMED WHEN SNAPPING THE STAPLER INTO THE VESSEL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.