BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 721987 · Received June 2, 2006

    Report

    Report Number
    1527736-2006-02494
    Event Type
    Malfunction
    Date Received
    June 2, 2006
    Date of Event
    May 9, 2006
    Report Date
    May 15, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A GALL BLADDER PROCEDURE, THE DEVICE WAS DROPPING CLIPS AND CLIPS DID NTO HOLD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER FZP FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA X43V1D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN