BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 8675993 · Received June 6, 2019

    Report

    Report Number
    3000719969-2019-00002
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    November 1, 2018
    Report Date
    January 3, 2019
    Manufacturer
    OLSEN MEDICAL, LLC
    Product Code
    GEI
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED AS IT WAS SENT WITH THE GENERATOR UNIT TO BE EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE WE HAVE COMPLETED OUR INVESTIGATION. THE DELAY IN THE FDA RECEIVING THIS COMPLAINT WAS DUE TO A CHANGE IN ESIGNATURE CERTIFICATES. THE REPORT WAS ORIGINALLY SENT ON (B)(6) 2019.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT DURING A SURGICAL SPINAL PROCEDURE, THE DOCTOR WAS USING A DISPOSABLE INSULATED BAYONET FORCEPS AND IT WAS NOT WORKING WHEN PLUGGED IN TO THEIR PREFERRED UNIT. THE RN SWITCHED TO A DIFFERENT CAUTERY MACHINE AND SWITCHED THE FOOT PEDALS AND OPENED NEW BAYONET FORCEPS THAT STILL DID NOT WORK. WHEN THE THIRD FORCEPS WAS OPENED, IT WORKED AND THE PROCEDURE WAS ABLE TO BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467405 OLSEN BAYONET BIPOLAR FORCEPS GEI OLSEN MEDICAL, LLC 108638

    Patients

    Seq Age Sex Outcome Treatment
    1