BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY RHOTON®

    MDR report key: 9511542 · Received December 23, 2019

    Report

    Report Number
    3007208013-2019-00038
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    November 1, 2019
    Report Date
    December 23, 2019
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    GDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS PURCHASED ON ONE OF THREE ORDERS FROM FEB 2019- MARCH 2019. THEREFORE IT HAD BEEN IN USE FOR APPROXIMATELY 8 MONTHS BEFORE THE DAMAGE OCCURRED. THE INSTRUMENT WAS MEASURED PER THE DRAWING SPECIFICATIONS AND TESTED FOR PROPERLY HARDNESS AND MATERIAL. ALL READINGS WERE FOUND TO BE WITH CONFORMANCE. THERE HAS BEEN TOTAL OF (B)(4) SOLD OF THIS PRODUCT SINCE 2012 WITH NO ADDITIONAL COMPLAINTS RECORDED FOR THIS OCCURRENCE. IT CAN BE DETERMINED THAT THE DAMAGE TO THE TIP WAS THE RESULT OF EXCESSIVE STRESS DURING USE. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS RECEIVED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NECESSARY CORRECTIVE ACTIONS A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A PITUITARY SURGERY, THE DOCTOR FOUND THAT THE TOP OF THE PRODUCT WAS BROKEN. THE DOCTOR CLOSED THE PATIENT BECAUSE THE PIECE WAS NOT OBSERVED BY X-RAY. HOWEVER, THE PIECE WAS OBSERVED IN THE PATIENT BODY BY CT SCREENING AFTERWARDS. A SECOND SURGERY WAS PERFORMED TO REMOVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305044 SYMMETRY RHOTON® NERVE HOOK GDG SYMMETRY SURGICAL INC 00058454

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention