BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1231184 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02893
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT A: CLIP. INSTRUMENT B: BATCH# E9F833, EXP DATE: 06/2013; MFG DATE: 07/12/2008; EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT ON EL5ML DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. HOWEVER, WHEN TESTING THE DEVICE FOR FUNCTIONALITY; THE FIRST FIRING HAD A DOUBLE FEED ISSUE; THE REMAINING 7 CLIPS WERE FED AND FORMED ACCORDING TO MANUFACTURING REQUIREMENTS. THE INSTRUMENT LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS FOUND BEYOND OF ITS INTENDED POSITION. CARE SHOULD BE TAKEN DURING FULL CYCLE OF THE TRIGGER TO ENSURE PROPER CLIP FEEDING AND CLIP FORMATION, AS PER THE WARNINGS AND PRECAUTIONS INCLUDED IN THE INSTRUCTIONS FOR USE: THE TRIGGER MUST BE FULLY SQUEEZED AGAINST THE HANDLE TO ENSURE COMPLETE CLIP FORMATION. ENSURE FULL RELEASE OF THE TRIGGER AFTER FIRING. A PARTIAL RELEASE OF THE TRIGGER MAY DISRUPT CLIP-FEEDING SEQUENCE AND MAY RESULT IN CLIP MALFUNCTION. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (B) WAS RECEIVED IN GOOD CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING 3 CLIPS WITHIN MANUFACTURING SPECIFICATIONS. THE INSTRUMENT LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, TWO DEVICES DID NOT FIRE. THEY GOT A THIRD DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4M758

    Patients

    Seq Age Sex Outcome Treatment
    1