BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALLOPIAN RING INSTRUMENT

    MDR report key: 15403 · Received January 10, 1994

    Report

    Report Number
    15403
    Event Type
    Malfunction
    Date Received
    January 10, 1994
    Date of Event
    September 7, 1993
    Report Date
    September 9, 1993
    Manufacturer
    CABOT MEDICAL
    Product Code
    HFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBAL GUN ASSEMBLED PRIOR TO SURGERY AND CHECKED BY SURGEON. SURGEON ATTEMPTED TO USE TUBAL GUN RESULTING IN LACERATION OF LEFT FALLOPIAN TUBE. SURGEON PROCEEDED WITH SURGERY UTILIZING CAUTERY. SURGEON REPORTED THAT TUBAL GUN MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALLOPIAN RING INSTRUMENT HFJ CABOT MEDICAL #002094-504

    Patients

    Seq Age Sex Outcome Treatment
    1 33 * Other