BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SURGICAL

    MDR report key: 11787642 · Received May 6, 2021

    Report

    Report Number
    3007208013-2021-00016
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    February 5, 2021
    Report Date
    May 6, 2021
    Manufacturer
    SYMMETRY SURGICAL
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY ALLEGES IN THEIR REPORT THAT THE FORCEPS "WAS BEING USED BY SURGEONS. THE TIP OF THE FORCEPS BROKE BUT WAS ABLE TO BE RETRIEVED." ACCORDING TO THE USER FACILITY, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. LIMITED INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME. HOWEVER, WE DO HAVE THE USER FACILITY REPORT THAT WAS MAILED TO US FROM THE FDA. WE WILL CONTINUE TO FOLLOW UP WITH THE USER FOR ADDITIONAL INFORMATION. THIS CAN BEEN SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS RECEIVED THAT ALLEGES ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORTER ALLEGED: "THRU-CUT STRAIGHT FORCEPS WAS BEING USED BY SURGEONS. THE TIP OF THE FORCEPS BROKE, BUT WAS ABLE TO BE RETREIVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684037 SYMMETRY SURGICAL SYMMETRY FORCEPS, WEIL-BLAKESLEY, STRAIGHT, THRU-CUTTING, 7 1/4 INCH KAE SYMMETRY SURGICAL CEAU05

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR