BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ENDOSCOPIC KIT

    MDR report key: 19974 · Received February 27, 1995

    Report

    Report Number
    MW1005222
    Event Type
    Malfunction
    Date Received
    February 27, 1995
    Date of Event
    January 23, 1995
    Report Date
    February 20, 1995
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC PROCEDURE, BALLOON ON PREPERITONEAL DISTAL BALLOON BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ENDOSCOPIC KIT ENDOSCOPIC KIT KOG ORIGIN MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR