BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLSEN FORCEPS

    MDR report key: 830113 · Received March 13, 2007

    Report

    Report Number
    1530493-2007-00008
    Event Type
    Other
    Date Received
    March 13, 2007
    Date of Event
    March 4, 2007
    Report Date
    March 13, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K884656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE, 20-1370 IS A NON-INSULATED BIPOLAR FORCEPS. THIS DEVICE WAS USED IN THE MOUTH. OUR INSTRUCTIONS FOR USE STATE THAT "DEVICE USE AND APPLICATION TO BE DETERMINED BY DOCTOR." INSULATED FORCEPS PROVIDE BETTER INSULATING PROPERTIES WHEN USED IN THE BODY. REPORTER ASKED IF WE PROVIDE AN INSULATED VERSION OF THIS FORCEPS. SHE WAS DIRECTED TO OUR PART NUMBER 20-1370I AND SHE FELT THEY WOULD PROBABLY ORDER THIS FORCEPS FOR FUTURE USE. ACCORDING TO REPORTER, THE ATTENDING PHYSICIAN TOUCHED THE PT IN THE MOUTH WITH PART OF THE FORCEPS CAUSING A BURN. PT REMEDIAL ACTION WAS NOT NEEDED AND THERE WAS NO EXTENDED HOSPITAL STAY BECAUSE OF THIS INCIDENT. NO LOT NUMBER WAS PROVIDED AND THERE WAS NO INDICATION THE DEVICE WOULD BE RETURNED.

    Description of Event or Problem · 1

    THE REPORTER WITH HOSPITAL CALLED OLSEN MEDICAL ON 03/06/07. THEY REPORTED THAT A PT RECEIVED A BURN IN OR NEAR THE MOUTH, WHILE THE SURGEON WAS USING ONE OF OUR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN FORCEPS BAYONET BIPOLAR FORCEPS GEI OLSEN MEDICAL 20-1370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other