BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1933232 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07265
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ORDER TO EVALUATE THE DEVICE'S INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING OF THE DEVICE, NO ANOMALIES WERE NOTED WITH THE INTERNAL COMPONENTS THAT COULD LEAD THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO OPEN AFTER FIRING. WHEN THE JAWS WERE EVENTUALLY OPENED, A SCISSORED CLIP WAS NOTICED AND THE CYSTIC ARTERY HAD A TEAR. NO EXCESSIVE BLEEDING OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO 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. UNK G4U19E

    Patients

    Seq Age Sex Outcome Treatment
    1