BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNOVIS BIPOLAR FORCEPS, MIDAS TOUCH

    MDR report key: 24012697 · Received January 8, 2026

    Report

    Report Number
    3002750084-2026-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Report Date
    February 12, 2026
    Manufacturer
    ASPEN SURGICAL PRODUTS, INC.
    Product Code
    LRW
    UDI-DI
    00844735006049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS IN PROCESS OF BEING RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. IT WAS SUBJECTED TO FUNCTIONAL TESTING (HIPOT AND CONTINUITY) USING A VOLTAGE OF 500 V, IN ACCORDANCE WITH IFU 0001331, WITH NO ANOMALIES DETECTED. THE COMPLAINT COULD NOT BE CONFIRMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "I RECEIVED A CALL WITH OUR CUSTOMER STATING THAT ALL 14 GEM BI-POLARS RECENTLY PURCHASED ARE NOT CAUTERIZING, SPARKING AND WILL NOT WORK CORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65973 SYNOVIS BIPOLAR FORCEPS, MIDAS TOUCH BIPOLAR FORCEPS LRW ASPEN SURGICAL PRODUTS, INC. GEM4025J-NS-S 485329 00844735006049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown