LIGAMAX
Received Jun 30, 2026 · Event occurred Apr 10, 2026
Report 3005075853-2026-05138 · MDR key 25669291
Device
Generic name
Clip, Implantable
Manufacturer
Ethicon Endo-surgery, Llc.Catalog number
EL5ML
Lot number
C9E95W
Product problems
- Failure to Fire
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4) DATE SENT: 6/30/2026 D4: BATCH # C9E95W. 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 AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS SUBJECTED TO FUNCTIONAL TESTING. DURING TESTING, IT WAS OBSERVED THAT THE CLIPS DID NOT ADVANCE INTO THE JAWS UPON SUBSEQUENT TRIGGER ACTUATION. TO FURTHER EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLY, THE FEED LINK WAS FOUND TO BE BROKEN, WHICH CAUSED THE FEEDING ISSUE. ADDITIONALLY, THIRTEEN (13) CLIPS WERE FOUND REMAINING WITHIN THE CLIP TRACK. THE EVENT IS RELATED TO IMPROPER USE OF THE DEVICE. POSSIBLE CAUSES FOR THE DAMAGE FOUND IS DUE TO THE JAWS MAY HAVE BEEN RESTRICTED DURING FIRING, OR NOT FULLY THROUGH THE TROCAR DURING FIRING. 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 C9E95W 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 INGUINAL LAPAROSCOPIC HERNIA REPAIR, THE EL5ML, ENDOSCOPIC MULTIPLE CLIP APPLIER, THE CLIPS DID NOT EJECT. NO PATIENT CONSEQUENCES WERE REPORTED.