BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1822375 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05008
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BROKEN JAW AT BIFURCATION, EMPTY. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (A) WAS RETURNED EMPTY WITH THE JAWS BROKEN AT BIFURCATION. THE MOST LIKELY REASON FOR JAW BIFURCATION BREAKAGE IS STRESS CORROSION CRACKING AND THE MOST LIKELY ROOT CAUSE IS EXPOSURE TO A SOLUTION CONTAINING CHLORINE. THIS CONDITION IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER POST-SURGERY DEVICE CLEANING. THE JAW BREAKAGE IS NOT OCCURRING AS A RESULT OF THE PRODUCT COMPLAINT DECONTAMINATION PROCESS. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS OF THE EL5ML DEVICE (B) FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; ONE PEAR SHAPED CLIP WAS RELEASED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT FIRED THE REMAINING FOUR CLIPS CONFORMING TO MANUFACTURING SPECIFICATIONS; HOWEVER, DURING EACH FIRING SEQUENCE THE JAWS REMAINED IN THE CLOSED POSITION. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE OPENING ISSUES. FINALLY, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR DID NOT SHOW UP. THESE FINDING ARE NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: (B)(4) JAWS UNABLE TO OPEN AFTER ASSISTED, MALFORMED CLIP, ORANGE INDICATOR. (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (C) WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY, LOCKED OUT AND THE ORANGE INDICATOR WAS NOT VISIBLE. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE C ADDITIONAL INFORMATION: (B)(4). EMPTY, ORANGE INDICATOR DID NOT SHOW UP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE DEVICES MISFIRED. THE CLIPS DROPPED OFF THE DEVICE UNFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TA6F

    Patients

    Seq Age Sex Outcome Treatment
    1