BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1812655 · Received August 24, 2010

    Report

    Report Number
    3005075853-2010-04824
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EJECTED CLIP, BROKEN JAW THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DUE TO THE ANTIBACKUP FEATURE BEING NON-FUNCTIONAL, TWO UNFORMED CLIPS WERE FED. DURING THE THIRD FIRING SEQUENCE, THE JAW RAMP WAS BROKEN AND THE REMAINING CLIPS WERE EJECTED DUE TO THIS CONDITION. THE DEVICE LOCKED OUT AS INTENDED. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL CAUSE OF THE BROKEN JAWS ISSUES. THE FOUND ANTIBACKUP FAILURE IS NOT RELATED TO THE INCIDENT REPORTED. 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 LAP CHOLECYSTECTOMY PROCEDURE, HE FOUND THAT THE CLIP FORMATION WAS IMPROPER AND ALSO FOUND THAT THE JAW OF THE APPLIER WAS NOT PARALLELED CLOSED. HE DISCARDED TO CONTINUE TO USE AND OPEN ANOTHER WITH ANOTHER LOT NUMBER TO COMPLETE THE SURGERY. NEEDED TO STOP TO USE AND PUT OUT THE IMPROPER FORMED CLIP INSIDE PATIENT. SURGERY WAS PROLONGED TEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4RY86

    Patients

    Seq Age Sex Outcome Treatment
    1