LIGACLIP

Description of Event or Problem

IT WAS REPORTED THAT DURING THE UNK SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

Additional Manufacturer Narrative

(B)(4). DATE SENT: 7/2/2026. D4: BATCH # 905D32. INVESTIGATION SUMMARY : THE PRODUCT WAS RETURNED TO EES FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE ER320 DEVICE WAS RECEIVED INSIDE ITS ORIGINAL PACKAGING UNOPENED. UPON INSPECTION OF THE PACKAGING, DAMAGE TO THE TYVEK MATERIAL WAS OBSERVED, SPECIFICALLY A HOLE LOCATED IN THE TRIGGER AREA. THE DAMAGE APPEARED TO ORIGINATE FROM THE INSIDE OUTWARD, CONSISTENT WITH PERFORATION CAUSED BY THE TRIGGER. AS A RESULT OF THIS CONDITION, THE STERILITY OF THE DEVICE WAS COMPROMISED. ADDITIONALLY, PHOTOS WERE PROVIDED AND THEY SHOWED THE CONDITION OF THE DEVICE RETURNED. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT AS PER CONDITIONS OF THE RETURNED DEVICE. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT 905D32 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.