BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1831611 · Received September 12, 2010

    Report

    Report Number
    3005075853-2010-05206
    Event Type
    Malfunction
    Date Received
    September 12, 2010
    Report Date
    August 18, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE CLIPS WERE NOT CLOSING PROPERLY. ONE SIDE WAS STRAIGHT AND THE OTHER SIDE WAS FORMED. TWO MORE DEVICES WERE PULLED AND THE SAME THING OCCURRED. A FOURTH DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE DEVICES WERE DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1