HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

(B)(4). REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS IS ONGOING, RESULTS ARE PENDING. (B)(4). THE COMPLAINT DEVICE HAS BEEN RECEIVED AND WILL BE INSPECTED BY OUR QA SUPERVISOR. (B)(4). THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

BEFORE AXILLARY ANASTOMOSIS, THE SURGEON FOUND THAT THE GRAFT WAS BENT, WITH A DIFFERENT SHAPE FROM WHAT HE USED TO SEE. AFTER CUTTING THE STRANGE PART, THE SURGEON STILL FELT SOMETHING WAS WRONG. SO HE REPLACED THE CONCERNED GRAFT WITH ANOTHER SAME MODEL GRAFT.

Additional Manufacturer Narrative

(3331/213) A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. THESE TESTS INCLUDE A 100% VISUAL INSPECTION OF THE GRAFT. (4109/213) THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. (10/170) A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS PERFORMED BY OUR QUALITY ASSURANCE (QA) SUPERVISOR. A DEFORMATION AT ONE END OF THE GRAFT WAS CONFIRMED. THIS DEFORMATION WAS PROBABLY PERFORMED DURING MANUFACTURING STEPS. (25) THE CONDUCTED INVESTIGATION INDICATED THAT THE ISSUE WAS PROBABLY RELATED TO HUMAN ERRORS DURING MANUFACTURING STEPS. THEREFORE, A NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO INVESTIGATE THE ROOT CAUSE AND TAKE APPROPRIATE CORRECTIVE ACTIONS IF NECESSARY.