BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIES NEEDLE

    MDR report key: 17001 · Received October 20, 1994

    Report

    Report Number
    MW1003736
    Event Type
    Malfunction
    Date Received
    October 20, 1994
    Date of Event
    September 30, 1994
    Report Date
    October 6, 1994
    Manufacturer
    STORZ INSTRUMENTS CO.
    Product Code
    FHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE WAS INSERTED INTO THE ABDOMEN AT THE INCISION SITE FOR A LAPAROSCOPY. ONCE THE NEEDLE WAS IN PLACE, CARBON DIOXIDE WAS INFUSED THROUGH CANNULA INTO THE ABDOMINAL CAVITY. WHEN THE CANNULA WAS REMOVED IT APPEARED THAT A PIECE WAS MISSING FROM THE INNER STYLUS. THE SURGEON LOCATED THE MISSING PIECE AT THE INCISION SITE AND REMOVED IT. NO INJURY WAS SUSTAINED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIES NEEDLE LAPAROSCOPY INSTRUMENT FHP STORZ INSTRUMENTS CO. 26120

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other