BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD WOLF MEDICAL INSTRUMENTS CORP.

    MDR report key: 457578 · Received May 1, 2003

    Report

    Report Number
    MW1028316
    Event Type
    Malfunction
    Date Received
    May 1, 2003
    Date of Event
    April 15, 2003
    Report Date
    April 30, 2003
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOOP ELECTRODES USED TO RESECT FIBROID IN THE UTERUS. TWO LOOP END PIECES BROKE OFF INTRA-UTERUS AND THE PHYSICIAN COULD NOT FIND THEM TO REMOVE THEM FROM THE PT. NO ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD WOLF MEDICAL INSTRUMENTS CORP. CUTTING LOOP ELECTRODE FDC RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8424-1310 24 FR. 275021

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR