BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SBT, 10MM

    MDR report key: 273151 · Received April 5, 2000

    Report

    Report Number
    1626598-2000-00025
    Event Type
    Malfunction
    Date Received
    April 5, 2000
    Date of Event
    February 25, 2000
    Report Date
    March 7, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, THE BALLOON RUPTURED. THE SURGEON WAS ABLE TO RETRIEVE THE PIECES AND APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN