BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 121686 · Received September 18, 1997

    Report

    Report Number
    1825883-1997-00003
    Event Type
    Malfunction
    Date Received
    September 18, 1997
    Date of Event
    August 5, 1997
    Report Date
    September 18, 1997
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING OPERATIVE PROCEDURE (ARTHROSCOPY OF RIGHT KNEE FOR LATERAL RETINACULAR RELEASE) THE HOOK TIP OF THE CAUTERY ELECTRODE FOR THE HAND-HELD COAGULATOR BROKE OFF AND EMBEDDED IN PT TISSUE. XRAYS DONE AND TIP RETRIEVED. OPERATIVE PROCEDURE PROLONGED BY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND-HELD HOOK TIP COAGULATOR COAGULATOR ELECTRODE GEI INSTRUMENT MAKAR, INC. 10798 19084

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other ARTHROSCOPE (8/5/97 TO 8/5/97) (STOP'D)