BEUDAMED
    FDA Adverse Event Summary report: N

    TRANSFER CARRIAGE

    MDR report key: 2763246 · Received September 27, 2012

    Report

    Report Number
    3005899764-2012-00073
    Date Received
    September 27, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 27, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    K010865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE CARRIAGE AND FOUND THAT THE RIGHT LOWER LATCH DID NOT LOCK. THE TECHNICIAN NOTED THAT THE SHAFT ON WHICH THE LATCH ROTATES HAD A BUILD-UP OF DEBRIS INTERFERING WITH THE FREE ROTATION OF THE LATCH, PREVENTING IT FROM LOCKING. THE TECHNICIAN CLEANED AND LUBRICATED THE LATCH MECHANISM AND PLACED THE TRANSFER CARRIAGE BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHILE LOADING INSTRUMENTS INTO THE STEAM STERILIZER, ONE OF THE TRANSFER CARRIAGE LATCHES DID NOT LOCK AND THE INSTRUMENT LOAD TIPPED AND HIT THE OPERATOR ON THE CHEST AS IT WAS BEING PUSHED INTO THE STERILIZER. THE OPERATOR WENT TO THE FACILITY ER AND RECEIVED AN X-RAY; IT WAS REPORTED THAT HE SUFFERED A FRACTURED RIB AND HAS RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFER CARRIAGE PLATFORM STERILIZER ACCESSORY FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1