BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUSABLE MONOPOLAR FORCEPS

    MDR report key: 1387704 · Received May 11, 2009

    Report

    Report Number
    1530493-2009-00002
    Event Type
    Other
    Date Received
    May 11, 2009
    Date of Event
    April 1, 2009
    Report Date
    May 11, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    PRE-AMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER-FACILITY WAS CONTACTED. WE ONLY REACHED THE ANSWERING MACHINE. NUMEROUS ATTEMPTS WERE MADE TO REACH THE REPORTING NURSE WITH NO SUCCESS. ONLY THE DEVICE NUMBER WAS PROVIDED, THERE WAS NO LOT NUMBER PROVIDED AND THE DEVICE WAS REQUESTED, BUT NOT RETURNED.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED REPORT FROM USER FACILITY ON 04/16/2009 AND THE FOLLOWING INFO. THE PT WAS HAVING A TONSILLECTOMY AND ADENOIDECTOMY. THE SURGEON WAS USING MEJELSKI FORCEPS TO CAUTERIZE THE BLOOD VESSELS AFTER REMOVING THE TONSILS AND ADENOIDS. THE INSULATION ON THE FORCEPS APPARENTLY WAS COMPROMISED BECAUSE THE HEAT FROM THEM BURNED THE PT'S LIPS AND SIDE OF HER MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE MONOPOLAR FORCEPS MONOPOLAR FORCEPS GEI OLSEN MEDICAL 41300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other