BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESECTOSCOPE CUTTING LOOP ELECTRODE

    MDR report key: 40331 · Received September 27, 1996

    Report

    Report Number
    1418479-1996-00015
    Event Type
    Injury
    Date Received
    September 27, 1996
    Date of Event
    August 28, 1996
    Report Date
    August 29, 1996
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FAS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ENDOMETRIAL ABLATION PROCEDURE WAS IN PROGRESS WHEN THE DOCTOR NOTICED THE WIRE CUTTING LOOP BEND BACKWARD ALMOST PARALLEL TO THE SHAFT. THE DOCTOR THEN STRAIGHTENED THE LOOP BACK TO A 90 DEGREE POSITION. UPON ACTIVATION OF CURRENT THE WIRE LOOP BROKE OFF AND THE UTERUS WAS PERFORATED. THE CASE WAS COMPLETED WITH SOME ADD'L LOOPS BEING BENT. A LAPAROTOMY WAS PERFORMED TO OVERSEW THE UTERUS. POST OPERATIVE RECOVERY OF THE PT IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESECTOSCOPE CUTTING LOOP ELECTRODE RESECTOSCOPE ELECTRODE FAS RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8424.1310 190961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention