BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1842793 · Received September 23, 2010

    Report

    Report Number
    3005075853-2010-05476
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER BYPASS, MALFORMED CLIP AFTER THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THE FOLLOWING RESPONSE WAS RECEIVED: UNFORTUNATELY I CANNOT GET ANY MORE INFO ON WHAT HAPPENED. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING, THE TIP OF THE ADVANCER SLID TOWARD THE TISSUE STOP DURING THE NEXT THREE CONSECUTIVE FIRING SEQUENCES CAUSING THE JAWS TO REMAIN IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WERE RELEASED. DURING THE NEXT FIRING SEQUENCE, THE CLIP WAS FORMED CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR DID NOT SHOW UP. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER LOCKED ON TO THE STRUCTURE AND JAWS WOULD NOT OPEN AS EXPECTED. THE HANDLES NEEDED TO BE PULLED APART TO RELEASE THE APPLIER FROM THE STRUCTURE. THE CLIP IS STILL LODGED IN THE APPLIER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4T49M

    Patients

    Seq Age Sex Outcome Treatment
    1