BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SBT, 10MM

    MDR report key: 286947 · Received July 19, 2000

    Report

    Report Number
    1626598-2000-00118
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    June 14, 2000
    Report Date
    June 22, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS LEAKING GAS AND A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SBT, 10MM 10MM SBT (STRUCTURAL BALLOON TROCAR) DRC UNITED STATES SURGICAL CORPORATION OMS-T10SB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN