BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN MEDICAL

    MDR report key: 19397234 · Received May 24, 2024

    Report

    Report Number
    3007208013-2024-00021
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Report Date
    May 24, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GEI
    UDI-DI
    00841785104565
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT ABLE TO BE RETURNED AS IT WAS DISCARDED AT THE FACILITY. THE CUSTOMER IS UNSURE IF THE ISSUE OCCURRED DUE TO THE FORCEPS OR THE CORD USED. THE CORD THAT WAS USED IS NOT AN ASPEN/SYMMETRY DEVICE. IT WAS NOT CONFIRMED IF THE CORD THAT WAS USED WAS AN ASPEN/SYMMETRY DEVICE. THE DHR FOR THE FOR THE PART LOT COMBINATION WAS REVIEWED AND FOUND TO HAVE NO NON-CONFORMANCES NOTED DURING THE MANUFACTURING PROCESS. BECAUSE THE DEVICE WILL NOT BE RETURNED, THE DEVICE CANNOT BE TESTED TO CONFIRM THE ISSUE AND DETERMINE A ROOT CAUSE. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES, "ONE OF THE BIPOLAR FORCEPS OLSEN® MIDAS TOUCH 8-1/4 INCH LENGTH NON LOCKING BAYONET HANDLE STRAIGHT SMOOTH INSULATED 1.5 MM TIPS WAS DEFECTIVE DURING SURGERY TODAY. NO OUTPUT WHEN THE DEVICE WAS PLUGGED IN. NO HARM TO THE PATIENT BUT A 10 MINUTE DELAY OCCURRED TO GET A NEW DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657998 OLSEN MEDICAL ELECTRODE GEI SYMMETRY SURGICAL INC. 20-1410IMT 134804 00841785104565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown