BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG

    MDR report key: 5973785 · Received September 23, 2016

    Report

    Report Number
    1423507-2016-00066
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 23, 2016
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ON (B)(6) 2016, CUSTOMER ADVOCACY SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT NUMBER, AND INQUIRING IF ADDITIONAL INFORMATION MAY BE AVAILABLE. CONFIRMATION WAS ALSO REQUESTED FROM THE CUSTOMER THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH REPORTED ISSUE. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    RECEIVED A REPORT OF FROM HEIDA MOORE AT (B)(6) HOSPITAL THAT THEY HAD A REPORT OF A CAUTERY CORD THAT POPPED/BURNT AT THE END THAT CONNECTS TO THE INSTRUMENT. IT HAPPENED WHEN THE DOCTOR HAND IT IN HAND, BUT THERE WAS NO HARM TO A PATIENT OR THE PHYSICIAN. I DON'T HAVE ACCESS TO THE SAMPLE ITSELF AS IT'S BEEN DISCARDED, BUT DO HAVE A PICTURE FROM (B)(6) THAT CAN BE RELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625020 UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLSEN MEDICAL 88-9199 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1