BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY KERRISON

    MDR report key: 7058635 · Received November 27, 2017

    Report

    Report Number
    7058635
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    August 23, 2017
    Report Date
    November 16, 2017
    Manufacturer
    SYMMETRY SURGICAL, INC.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN LIGHT OF TRACKING AND TRENDING FOR DEBRIS ON STERILE INSTRUMENTS, IT WAS NOTED THAT THE SYMMETRY KERRISON'S WERE FOUND WITH BIOBURDEN AFTER STERILIZATION ON MULTIPLE OCCASIONS. SEVERAL TIMES PER WEEK WE HAD AN OUTSIDE VENDOR TO COME AND TAKE APART THE KERRISONS FOR STERILIZATION AND FOUND COPIOUS BONE FRAGMENTS AND BIOBURDEN INSIDE THE INSTRUMENTS. OUR PROCESS AT THAT TIME WOULD BE TO STERILIZE THESE INSTRUMENTS PER MANUFACTURERS GUIDELINES IN BETWEEN THE OUTSIDE VENDOR STERILIZATIONS. THE AMOUNT OF BIOBURDEN LEFT INSIDE THESE KERRISONS WAS UNACCEPTABLE AND WE STOPPED USING THEM. WE TRANSITIONED TO THE BLACK SYMMETRY KERRISON'S THAT WERE NOT REQUIRED TO TAKE APART TO CLEAN. THESE BLACK KERRISONS WERE NOT SAFE TO USE. WE HAD SEVERAL COMPLAINTS FROM SURGEONS THAT THEY WERE DANGEROUS, AND HARD TO USE. THERE IS A SEPARATE REPORT FOR THAT INSTRUMENTATION. WE REVERTED BACK TO THE OLD KERRISON'S AND PUT A PLAN IN PLACE THAT WE WOULD NOT UTILIZE THE INSTRUMENTATION UNTIL THE OUTSIDE VENDOR HAD TAKEN THEM APART TO STERILIZE THEM COMPLETELY BETWEEN EACH CASE. MANUFACTURER RESPONSE: FOR SYMMETRY KERRISON, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE DEPARTMENT DIRECTOR HAS BEEN IN CONTACT WITH THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840133 SYMMETRY KERRISON RONGEUR, MANUAL HAE SYMMETRY SURGICAL, INC. 53-1417, 53-1514, 53-1515, 53-1512, AND 53-1414

    Patients

    Seq Age Sex Outcome Treatment
    1 NO