BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CORD, VALLEYLAB STYLE GENERATOR PLUG

    MDR report key: 1853195 · Received September 27, 2010

    Report

    Report Number
    1530493-2010-00007
    Event Type
    Other
    Date Received
    September 27, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 27, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED TO OLSEN MEDICAL ON 9/1/2010. WE REQUESTED THE DEVICE BE SENT BACK TO OLSEN MEDICAL AND AGAIN ON 9/23/2010, BUT WE WERE TOLD THE HOSP WILL NOT BE SENDING THE DEVICE BACK. THE DHR WAS REVIEWED AND THERE ARE NO ASSOCIATED NONCONFORMANCES ASSOCIATED WITH THE DHR. PREVIOUS SIMILAR COMPLAINTS ARE ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 1

    ON 9/1/2010, OLSEN MEDICAL RECEIVED INFO FROM A DISTRIBUTOR THAT AN OLSEN MEDICAL DEVICE HAD CAUGHT FIRE IN AN OPERATING ROOM. THE END-USER, (B)(6) MEDICAL CENTER, HAD REPORTED TO THE DISTRIBUTOR ON 9/1/2010 THAT DURING A LAP CHOLE PROCEDURE, THE CORD FROM THE GENERATOR TO THE DEVICE HAD CAUGHT FIRE DURING, AND BURNED ITSELF AWAY FROM THE PLUG. THERE WAS NO PT INJURY SO, THERE WAS NO PT INFO OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CORD, VALLEYLAB STYLE GENERATOR PLUG REUSABLE MONOPOLAR FORCEPS GEI OLSEN MEDICAL 90056 014589

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other