BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1181657 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01978
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    July 17, 2008
    Report Date
    September 8, 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 HERNIA REPAIR PROCEDURE, THE TIP WOULD NOT OPEN. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO 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 E4LA6P

    Patients

    Seq Age Sex Outcome Treatment
    1