BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY OLSEN

    MDR report key: 13544889 · Received February 16, 2022

    Report

    Report Number
    3000719969-2021-00003
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Report Date
    December 7, 2021
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785102820
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER MADE REFERENCE TO AN FDA REPORT REGARDING THIS INCIDENT ON 11/12/2021. WE HAVE NOT RECEIVED A COPY OF THIS REPORT TO DATE. UPON RECEIVING THE DEVICE FOR EVALUATION, IT WAS TESTED FOR PROPER FUNCTIONALITY. THE DEVICE FUNCTIONED AS INTENDED AND WAS FOUND TO BE WITHIN CONFORMANCE PER THE PRODUCT SPECIFICATIONS. IF THE TIPS OF THE DEVICE WERE TOUCHING WHEN THE DEVICE WAS PLUGGED INTO THE GENERATOR AND ACTIVATED, ARCING OF THE TIPS WOULD OCCUR. THIS ARCING WOULD EXPLAIN THE POP THAT THEY HEARD UPON ACTIVATION. THE DHR FOR THIS LOT NUMBER WAS REVIEWED AND IT WAS CONFIRMED THAT ALL ITEMS WITHIN THIS LOT WERE WITHIN CONFORMANCE PER THE PRODUCT SPECIFICATIONS PRIOR TO SHIPPING. THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF ALL LOTS WITH NO ADDITIONAL COMPLAINTS RECORDED FOR THIS OCCURRENCE. THIS IS AN ISOLATED EVENT. BASED ON THE ABOVE INFORMATION, THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS SUBMISSION IS PASSED DUE AS WE RECENTLY DISCOVERED THAT THE ORIGINAL SUBMISSION WAS NOT ACCEPTED DUE TO AN OLD VERSION OF ESUBMITTER.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT THE TIPS OF THE FORCEPS POPPED WHEN THEY WERE PLUGGED INTO THE GENERATOR AND ACTIVATED. THERE WAS NO HARM TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872689 SYMMETRY OLSEN JEWELERS BIPOLAR FORCEP GEI OLSEN MEDICAL LLC 20-1060KI-28 118021 00841785102820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown