BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDCLEAN(R)

    MDR report key: 5107878 · Received September 18, 2015

    Report

    Report Number
    3007208013-2015-00022
    Date Received
    September 18, 2015
    Date of Event
    July 14, 2015
    Report Date
    September 18, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HTX
    UDI-DI
    00887482102527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RAPIDCLEAN CERAMIC COATED CONVERTIBLE MICRO KERRISON RONGEUR SCREW/PIN THAT SITS IN THE TOP PORTION OF THE KERRISON CAME APART FROM THE MAIN SHAFT. CONTRACT MANUFACTURER EVALUATED THE DEVICE INDICATING: THE SCREW CAME LOOSE, CAUSING MALFUNCTION. DEVICE WAS REPAIRED; SCREW WAS SECURED. CONTRACT MANUFACTURER INDICATED; THROUGH INADEQUATE MAINTENANCE OF THE INSTRUMENT MAY CAUSE THE SCREW LOCK TO SWITCH OFF. PROPER INSTRUCTIONS FOR USE OF MAINTAINING INSTRUMENTS (IFU) ARE BEING PROVIDED TO THE CUSTOMER. REPORT RECEIVED 17-SEPT-2015.

    Description of Event or Problem · 1

    THE SCREW/PIN THAT SITS IN THE TOP PORTION OF THE KERRISON CAME APART FROM THE MAIN SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619405 RAPIDCLEAN(R) CERAMIC COATED CONVERTIBLE MICRO KERRISON RONGEUR HTX SYMMETRY SURGICAL INC. 58-3200J-BD BJ1113 00887482102527

    Patients

    Seq Age Sex Outcome Treatment
    1