BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 22992163 · Received September 8, 2025

    Report

    Report Number
    3005075853-2025-07085
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    10705036001843
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT 9/8/2025. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT 9/22/20253. THE DEVICE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT 9/25/2025. D4 BATCH #Z7025N. 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 EL5ML DEVICE WAS RETURNED WITH NO APPARENT DAMAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED EIGHT(8) CONFORMING CLIPS. UPON TESTING, THE JAWS OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. AS PART OF ETHICON¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. DO NOT EXCESSIVELY TWIST OR TORQUE THE INSTRUMENT JAWS WHEN POSITIONING OR FIRING THE INSTRUMENT ON A TUBULAR STRUCTURE OR VESSEL. EXCESSIVE TWISTING OR TORQUING MAY RESULT IN CLIP MALFORMATION. DO NOT INSERT THE CLIP APPLIER THROUGH A TROCAR IF A CLIP IS PRESENT IN THE JAWS. THIS MAY RESULT IN CLIP MALFORMATION, DISLODGED CLIPS, OR DAMAGE TO THE INSTRUMENT. IF A CLIP IS PRESENT IN THE JAWS, FULLY SQUEEZE THE TRIGGER AGAINST THE HANDLE, THEN FULLY RELEASE THE TRIGGER TO RELEASE THE CLIP FROM THE JAWS BEFORE INSERTING THE DEVICE THROUGH THE TROCAR. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH Z7025N NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE SALES REP REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP IN THE DEVICE DID NOT CLOSE ALL THE WAY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418196 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. Z7025N 10705036001843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown