BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN® BIPOLAR FORCEPS KIT, ADSON

    MDR report key: 22056377 · Received May 20, 2025

    Report

    Report Number
    3007208013-2025-00017
    Event Type
    Injury
    Date Received
    May 20, 2025
    Report Date
    June 17, 2025
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GEI
    UDI-DI
    00841785103001
    PMA / PMN Number
    K130669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE ATTEMPTING TO HAVE THE DEVICE RETURNED. THE INVESTIGATION IS ONGOING, AND WE ARE CONTINUING TO TRY TO GET MORE INFORMATION ABOUT THE INCIDENT. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EVALUATED, AND MANY TESTS WERE PERFORMED INCLUDING DIMENSIONAL TESTS, HIPOT, AND CONTINUITY TESTS, WITH NO DISCREPANCIES FOUND IN RELATION TO THE ESTABLISHED SPECIFICATIONS. THE DHR WAS CHECKED, AND NO ANOMALIES WERE FOUND. THE WORK INSTRUCTIONS AND DRAWINGS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THIS COMPLAINT COULD NOT BE CONFIRMED, AND NO ROOT CAUSE WAS ABLE TO BE IDENTIFIED. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES THAT A PATIENT WAS BURNED WITH OUR BIPOLAR UNIT DURING AN OPEN NECK PROCEDURE. THE PATIENT'S TRACHEA WAS BURNED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES THAT A PATIENT WAS BURNED WITH OUR BIPOLAR UNIT DURING AN OPEN NECK PROCEDURE. THE PATIENT'S TRACHEA WAS BURNED, CREATING A HOLE IN THE TRACHEA. THE PATIENT WAS LEFT INTUBATED IN THE ICU OVERNIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35597 OLSEN® BIPOLAR FORCEPS KIT, ADSON BIPOLAR FORCEPS KIT GEI SYMMETRY SURGICAL INC. 20-1082KI 00841785103001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention