LIGACLIP

Additional Manufacturer Narrative

(B)(4) DATE SENT: 6/30/2026 D4: BATCH # Z7053C. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO EES FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE ER320 DEVICE WAS RECEIVED WITH THE JAWS IN A CLOSED POSITION AND NO APPARENT EXTERNAL DAMAGE. THE OPENED PACKAGING WAS ALSO RETURNED ALONG WITH THE INSTRUMENT. TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS SUBJECTED TO FUNCTIONAL TESTING; HOWEVER, THE TRIGGER COULD NOT BE ACTIVATED DUE TO JAMMING. THE DEVICE WAS SUBSEQUENTLY DISASSEMBLED TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS. EXAMINATION REVEALED THAT THE TRIGGER WAS BENT, PREVENTING PROPER FEEDING OF THE CLIPS INTO THE JAWS. ADDITIONALLY, FIFTEEN (15) CLIPS WERE FOUND REMAINING WITHIN THE CLIP TRACK. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH Z7053C 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS COULDN'T BE FIRED OUT. NO PATIENT CONSEQUENCES WERE REPORTED.