BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SURGICAL

    MDR report key: 19784446 · Received July 19, 2024

    Report

    Report Number
    3007208013-2024-00034
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 18, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED PARTS (PART# 80-1531) FROM THE LOT (LOT# 823832) WERE REVIEWED AND DID NOT FIND ANY NERVE HOOKS THAT WERE MISSING THE 3.00 MM BALL TIP. THE REPORTED PART WAS DISCARDED BY THE HOSPITAL AND LOT NUMBER IS UNKNOWN. WITHOUT FURTHER INFORMATION THE ROOT CAUSE IS UNKNOWN. 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

    PER THE COMPLAINANT, "WE JUST HAD 3MM BALL TIP PROBE 80-1531 BREAK OFF INTO THE PATIENT. CONFIRMED ALL PIECES REMOVED AND CONFIRMED BY X-RAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753788 SYMMETRY SURGICAL HOOK GDG SYMMETRY SURGICAL INC. 80-1531 823832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown