BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSI

    MDR report key: 283239 · Received June 23, 2000

    Report

    Report Number
    283239
    Event Type
    Malfunction
    Date Received
    June 23, 2000
    Date of Event
    June 15, 2000
    Report Date
    June 22, 2000
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY IT WAS NOTED THAT THE BALLOON WAS DEFECTIVE. UPON REMOVING TROCAR IT WAS APPARENT THAT THERE WAS A DEFECT WITH THE BALLOON COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSI BALLOON TIP CANNULA GDI GENERAL SURGICAL INNOVATIONS BTC 400X 001004

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other