LIGACLIP*ENDO MED/LG APPLIER

Additional Manufacturer Narrative

(B)(4). DATE SENT: 1/8/2026. 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 EL314 DEVICE WAS RECEIVED WITH SLIGHTLY SCRATCHES ON THE SHAFT. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED 6 CLIPS AS INTENDED; THE DEVICE ROTATED WITHOUT DIFFICULTY AND THE JAWS AND HANDLE WORKED AS EXPECTED. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE KNOB ROTATION WAS EXPECTED AND NO SCISSORED CLIPS WERE OBSERVED. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICE HISTORY REVIEW AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION.

Additional Manufacturer Narrative

(B)(4). DATE SENT 1/27/2026. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE EL314 DEVICE WAS RECEIVED WITH SLIGHTLY SCRATCHES ON THE SHAFT. ADDITIONALLY, A PHOTO WAS PROVIDED AND IT SHOWED THE CONDITION OF THE REPORTED EVENT. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED 6 CLIPS AS INTENDED; THE DEVICE ROTATED WITHOUT DIFFICULTY AND THE JAWS AND HANDLE WORKED AS EXPECTED. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE KNOB ROTATION WAS EXPECTED AND NO SCISSORED CLIPS WERE OBSERVED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION.

Additional Manufacturer Narrative

(B)(4). DATE SENT: 12/17/2025. D4: BATCH # UNK. THE DEVICE/PHOTO UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE ROTATION PART MENTIONED IN DESCRIPTION IS CHECKED AND FOUND THAT THE LOCK IS SOMEWHAT TIGHT. BUT AS FIRED WITH THE LT300 CLIPS, THE CLIPS ARE GETTING TWISTED. OUT OF 4 CLIPS FIRED 2 TWISTED. WE ALSO HAVE A PICTURE FROM THE HOSPITAL SHOWING A TWISTED CLIP. WHEN COMPLAINT WAS RAISED. CHECKED IN PERSON ALSO. 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, BOTH THE ROTATING KNOB IS NOT WORKING, DEVICE NOT FUNCTIONING CORRECTLY. NO PATIENT CONSEQUENCES WERE REPORTED.