BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 24620716 · Received March 17, 2026

    Report

    Report Number
    3005075853-2026-02060
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    10705036001843
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/8/2026. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HAVE YOU IDENTIFIED THE SAME ISSUE FOR ALL DEVICES INVOLVED? NO. IF NOT, PLEASE EXPLAIN IN DETAIL WHAT THE PROBLEM WAS WITH THE OTHER DEVICES. IS THE DEVICE BLOCKED (NO CLIPS TRIGGERED)? NO. HAS THE DEVICE NOT INSERTED THE CLIPS (THE CLIPS DO NOT FULLY ADVANCE INTO THE JAWS)? YES 3 CLIPS IN PLACE IN PATIENT. DID THE DEVICE DROP OR EJECT THE CLIPS? NO. WAS THERE ANOTHER PROBLEM WITH THE RELEASE OF THE CLIP (LATERALLY POWERED CLIPS , MALFORMED CLIPS , SCISSOR CLIPS, ETC.)) ? IMPROPERLY SHAPED CLIP. DIDN¿T THE CLIP HOLD ONTO THE VESSEL OR TISSUE ONCE IN PLACE? IF, BUT IN DOUBT, THIS HAS BEEN CHANGED DUE TO IMPROPER CLOSURE. WAS THE DEVICE PLACED ON A VESSEL/ARTERY WHEN IT DID NOT OPEN? NO. OIF YES, HOW WAS THE DEVICE REMOVED? (CUT, FORCED OPEN). OIF THE DEVICE WAS CUT, WAS THE VESSEL/TISSUE DAMAGED? IS THE CURRENT CONDITION OF THE PATIENT KNOWN? NO. DID THE EVENT RESULT IN A CONSEQUENCE OR CHANGE IN THE PATIENT¿S POSTOPERATIVE CARE? NO.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/17/2026. D4 BATCH #: UNKNOWN. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT: DID DEVICE JAM (NOT FIRE CLIPS)? DID DEVICE NOT FEED CLIPS (CLIPS NOT ADVANCE FULLY INTO JAWS)? DID DEVICE DROP OR EJECT CLIPS? WAS THERE ANY OTHER ISSUE NOTED WITH THE CLIP FIRING (SIDEWAYS FEED CLIP, MALFORMED CLIPS, SCISSORED CLIPS, ETC )? DID THE CLIP NOT HOLD ON THE VESSEL OR TISSUE ONCE PLACED? WAS THE DEVICE ON A VESSEL/ARTERY WHEN IT WOULD NOT OPEN? IF YES, HOW WAS THE DEVICE REMOVED? (CUT OFF, FORCED OPEN) IF THE DEVICE WAS CUT OFF, WAS THERE ANY DAMAGE TO THE VESSEL/TISSUE? IS THE CURRENT PATIENT STATUS KNOWN? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE 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 · 0

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, AFTER 3 POSITIONS OF THE CLIPS, IT IS OBSERVED THAT THE APPLICATOR DOES NOT CLOSE PROPERLY. IMMEDIATE MEASURES: "EMPTY" VERIFICATION OF THE CLOSURE OF THE CLIPS AN INCOMPLETE CLOSURE OF THE CLIPS IS OBSERVED. CHANGE OF APPLICATOR AND REINFORCEMENT WITH NEW CLIPS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676294 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. A98W5V 10705036001843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown