BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION

    MDR report key: 1033391 · Received April 22, 2008

    Report

    Report Number
    MW5006369
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP BROKE OFF OF INSTRUMENT OUTSIDE OF PT. TIP FOUND ON DRAPE. DATES OF USE: USED ONCE IN 2008. DIAGNOSIS OR REASON FOR USE: CHRONIC ACALCULOUS CHOLECYSTITIS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 5/5/2008: TIP DID NOT COME OFF OUTSIDE OF THE PT. IT CAME OFF INSIDE PT. SURGEON WAS ABLE TO REMOVE BOTH THE TIP AND THE DEVICE. THERE WAS NO INJURY TO PT THAT THEY KNOW OF. NURSE HAD TURNED AWAY, HENCE INITIAL REPORT OF TIP BREAKING OFF OUTSIDE OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION 5MM CURVED SHEARS WITH PISTOL GRIP LFL ETHICON ENDO-SURGERY, INC. LCSC5 D4H456

    Patients

    Seq Age Sex Outcome Treatment
    1