BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY

    MDR report key: 14516520 · Received May 26, 2022

    Report

    Report Number
    3007208013-2022-00017
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    March 9, 2022
    Report Date
    June 15, 2022
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    GEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY REPORT MW5108659 WAS RECEIVED IN THE MAIL ON 05/03/2022. NO FURTHER INFORMATION HAS BEEN RECEIVED YET. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE MORE INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 6/9/2022: - THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DESTROYED AND NO PICTURES WERE TAKEN. - A PIECE FELL INTO THE PATIENT, IT WAS AT THE BEGINNING OF THE CASE. THE PIECES WERE RETRIEVED WITH NO HARM TO THE PATIENT OR IMAGING REQUIRED. WITHOUT THE RETURN OF THE DEVICE OR PICTURES, IT CANNOT BE CONFIRMED WHERE THE DEVICE BROKE. ADDITIONALLY, ROOT CAUSE CANNOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION. THIS IS THE FIRST COMPLAINT RECORDED WITH (B)(4). BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT UPON STARTING THE CRANIOTOMY, THE DEVICE BROKE. ALL PIECES WERE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331536 SYMMETRY ADSON ELEVATOR GEG SYMMETRY SURGICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown