BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH-BLADE

    MDR report key: 1013890 · Received March 7, 2008

    Report

    Report Number
    1013890
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 7, 2008
    Manufacturer
    SNOWDEN-PENCER, INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE LAPAROSCOPIC METZENBAUM SCISSORS, THE DISPOSABLE TIP FELL OFF THE SHAFT OF THE INSTRUMENT INTO THE PATIENT'S ABDOMEN. THE TIP WAS RETRIEVED ENDOSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWITCH-BLADE SCISSORS, CURVED METZENBAUM TIP, DISPOSABLE LRW SNOWDEN-PENCER, INC. * 804114

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR