BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD WOLF MEDICAL INSTRUMENTS CORP.

    MDR report key: 168933 · Received May 20, 1998

    Report

    Report Number
    168933
    Event Type
    Malfunction
    Date Received
    May 20, 1998
    Date of Event
    March 2, 1998
    Report Date
    April 7, 1998
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN GYN O.R. FOR LAPAROSCOPY, HYSTEROSCOPY, DILATATION, CURETTAGE, APPENDECTOMY. AS TUBESAND OVARIES BEING CHECKED WITH DYE ON RIGHT THEN LEFT SIDES, O.R. TECH NOTICED THE BIPOLAR CAUTERIZING MACHINE HAD "FIRED" (THERE IS AN AUDIBLE TONE WHEN MACHINE IS FIRING), AND TOLD DR WHO SAID SHE WAS UNAWARE. TECH THEN ASKED DR "IS YOUR FOOT ON THE PEDAL? DR SAID, "MY FOOT WASN'T ON CONTROLS, CONTROLS ARE A FOOT AWAY FROM ME." THEY THEN PANNED BACK OVER AREA AND SAW WHITE AREA ON LEFT FALLOPIAN TUBE AND SMOKE. MACHINE TAKEN OUT OF SERVICE, DYE IN TUBES CHECKED AND WOULD NOT GO THROUGH THE TUBE AS FAR AS IT HAD BEFORE. DR SAID IMMEDIATELY THAT SHE WOULD TELL THE PT'S FAMILY THAT THE CAUTERY UNIT HAD FIRED ON ITS OWN." IT IS FACILITY'S UNDERSTANDING THAT THE PT WAS IN A FERTILITY PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD WOLF MEDICAL INSTRUMENTS CORP. BIPOLAR CAUTERIZING MACHINE KNS RICHARD WOLF MEDICAL INSTRUMENTS 2352.011 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other