LIGAMAX

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WAS WAS MALFUNCTIONING. NO PATIENT CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

(b)(4).DATE SENT: 7/8/2026.D4: BATCH # X7043N.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 DETERMINED THAT THE EL5ML DEVICE WAS RECEIVED WITH NO DAMAGE TO THE EXTERNAL COMPONENTS. IN ADDITION, THE PACKAGING OPENED WAS RETURNED ALONG WITH THE INSTRUMENT. UPON CYCLING, THE INSTRUMENT WAS OBSERVED TO BE EMPTY AND IN A LOCKED-OUT CONDITION. THE DEVICE WAS SUBSEQUENTLY DISASSEMBLED TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS. UPON DISASSEMBLY, THE ADVANCER WAS FOUND TO BE BENT, AND THE INSTRUMENT WAS CONFIRMED TO BE EMPTY. BASED ON DEVICE HISTORY, A BENT ADVANCER CONDITION MAY RESULT IN A ¿WOULD NOT FIRE¿ ISSUE.THE EVENT IS RELATED TO IMPROPER USE OF THE DEVICE. PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE, COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.DEVICE HISTORY REVIEW:A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH X7043N NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED:HOW DID DEVICE NOT WORK? I AM TOLD ON THE FIRST USE THE CLIP WOULD NOT FIRE.DID DEVICE JAMMED (NOT FIRE CLIPS)? I AM TOLD THE DEVICE DID NOT FIRE THE CLIP AS INTENDED. ASSUMING THE DEVICE JAMMED.DID DEVICE NOT FEED CLIPS? I AM TOLD THE CLIP WAS NOT EXPELLED FROM THE CLIP APPLIER.DID DEVICE DROP OR EJECT CLIPS?NO.DID DEVICE SIDEWAYS FEED CLIPS? NOT THAT THEY WERE AWARE OF.DID DEVICE FIRE MALFORMED CLIPS? DEVICE WOULD NOT FUNCTION AS INTENDED.DID DEVICE FIRE SCISSORED CLIPS?NOT THAT THEY ARE AWARE OF.IF OTHER PLEASE SPECIFY.HOW DID DEVICE NOT WORK? I AM TOLD ON THE FIRST USE THE CLIP WOULD NOT FIRE. DID DEVICE JAMMED (NOT FIRE CLIPS)? I AM TOLD THE DEVICE DID NOT FIRE THE CLIP AS INTENDED. ASSUMING THE DEVICE JAMMED.DID DEVICE NOT FEED CLIPS? I AM TOLD THE CLIP WAS NOT EXPELLED FROM THE CLIP APPLIER.DID DEVICE DROP OR EJECT CLIPS? NO.DID DEVICE SIDEWAYS FEED CLIPS? NOT THAT THEY WERE AWARE OF.DID DEVICE FIRE MALFORMED CLIPS? DEVICE WOULD NOT FUNCTION AS INTENDED.DID DEVICE FIRE SCISSORED CLIPS? NOT THAT THEY ARE AWARE OF.IF OTHER PLEASE SPECIFY.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.