APPLIER, HEMOSTATIC CLIP

Additional Manufacturer Narrative

(B)(4). DATE SENT: 4/7/2026. B3: EXACT EVENT DATE UNK, ENTERED 1/1/2026 AS ONLY THE YEAR WAS PROVIDED. D4: BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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, SURGEON WAS USING OUR LIGACLIP (ENDOSCOPIC APPLIER) IN SURGERY & WHILE APPLYING THE CLIP, THE CLIP IS NOT HOLDING BACK AND SLIPS OUT. NO PATIENT CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

(B)(4). DATE SENT: 4/24/2026. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO-SURGERY FOR THOROUGH EVALUATION, WHICH INCLUDED VISUAL INSPECTIONS AND FUNCTIONAL TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE EL314 DEVICE WAS RECEIVED WITH NO APPARENT DAMAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY AND THE KNOB ROTATED FREELY WITHOUT DIFFICULTIES NOTED. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED 6 CLIPS AS INTENDED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITHOUT DETECTABLE DAMAGE. AS PART OF ETHICON ENDO SURGERY¿S 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 LOT NUMBER FQGA16905, AND NO NON-CONFORMANCES WERE IDENTIFIED.