BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3923750 · Received July 9, 2014

    Report

    Report Number
    3005075853-2014-04786
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 23, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY PATIENT CONSEQUENCE? HAD TO RECLIP THE DUCT TWICE. PROCEDURE NAME? LAPAROSCOPIC CHOLECYSTECTOMY. HOW THE PROCEDURE WAS COMPLETED? OPENING ANOTHER CLIP APPLIER. DID THE CLIP FALL OFF THE DUCT INTRA-OP OR POST-OP? INTRA-OP. IF POST-OP HOW WAS THE LEAK REPAIRED? WHAT WAS THE SHAPE OF THE CLIP? U.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP DOES NOT CLOSE ALL THE WAY - SLIPS OFF THE DUCT. THERE WERE NO PATIENT CONSEQUENCES. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. ONE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401491 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1