BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMO WASHER

    MDR report key: 635602 · Received September 15, 2005

    Report

    Report Number
    8043405-2005-00001
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Date of Event
    January 4, 2005
    Report Date
    August 15, 2005
    Manufacturer
    STERIS AG
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN EYE LENS EXTRACTION SURGERY, A SURGEON OBSERVED GRAY DEBRIS AT THE SLIT LINE MADE FROM SCISSOR BLADES. THE DEBRIS WAS REMOVED FROM THE EYE AND SENT TO AN OUTSIDE LAB FOR TESTING. TESTING DETERMINED THE DEBRIS TO BE SMALL METALLIC PARTICLES. AN ADDITIONAL EXAMINATION WAS CONDUCTED ON ALL REMAINING ITEMS IN THE INSTRUMENT CASE AND THE CASE ITSELF. METALLIC PARTICLES WERE DISCOVERED ON THE ITEMS AND IN THE CASE AS WELL. THE OUTSIDE LAB WHO TESTED THE ITEMS HAS QUESTIONED WHETHER THE STERIS HAMO WASHER USED IN CLEANING THE INSTRUMENTS WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMO WASHER WASHER - DISINFECTOR T-21 LRJ STERIS AG T-21 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention