BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1170356 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01665
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Report Date
    August 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CERVICAL HYSTERECTOMY PROCEDURE, THE CLIPS WERE TWISTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC. NA E4KR76

    Patients

    Seq Age Sex Outcome Treatment
    1