BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2002755 · Received February 28, 2011

    Report

    Report Number
    3005075853-2011-00770
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 2, 2011
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER, CLIP. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION; THE JAWS WERE INSPECTED AND NO BURR WAS FOUND. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, TWO CLIPS WERE FED AT THE SAME TIME. IT IS POSSIBLE THAT THE FEEDING ISSUE OCCURRED AS A RESULT OF THE TRIGGER NOT ENGAGING THE ANTI-BACKUP RATCHET PRIOR TO RELEASING. DURING THE NEXT FIRING SEQUENCE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING ONE FIRING SEQUENCE CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. THE REMAINING CLIPS WERE FIVE CLIPS WITH GAP AND TWO CONFORMING CLIPS; NO J SHAPED CLIPS WERE NOTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND CLIPS WITH GAP. A POSSIBLE CAUSE OF THE EVENT REPORTED MAY BE THAT THE DEVICE WAS FIRED WITH A CLIP JAMMED IN THE JAWS. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE STARTED TO FORM MALFORMED CLIPS IN THE SHAPE OF A J SHAPE. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TT3F

    Patients

    Seq Age Sex Outcome Treatment
    1