BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS CORP.

    MDR report key: 471055 · Received July 8, 2003

    Report

    Report Number
    MW1028933
    Event Type
    Malfunction
    Date Received
    July 8, 2003
    Manufacturer
    STERIS CORP.
    Product Code
    MLR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON AT LEAST FOUR OCCASIONS WITHIN A MONTH'S TIME, THE PENTAX ENDOSCOPES HAVE BECOME DAMAGED BY FLUID INVASION AFTER HAVING BEEN REPROCESSED IN THE STERIS SYSTEM 1 STERILIZER/AUTOMATED ENDOSCOPE REPROCESSOR. FOUR PENTAX ENDOSCOPES HAVE BECOME DAMAGED DUE TO A NORMALLY FIXED SCOPE PART (AIR/WATER PORT) THAT HAS LOOSENED THUS COMPROMISING THE WATERTIGHT INTEGRITY OF THE INSTRUMENTS AND ALLOWING FLUIDS TO ENTER (AND DAMAGE) THE ENDOSCOPES. THE PROBLEM STEMS FROM COMPONENTS OF THE STERIS QPC QUICK CONNECT WHOSE METAL ADAPTER SCREWS ONTO THE PENTAX ENDOSCOPE AIR/WATER CHANNEL PORT. DURING NORMAL USE OF THIS STERIS QUICK CONNECT, THE STERIS ADAPTER CAN BECOME "STUCK" ONTO THE PENTAX AIR/WATER PORT. WHEN ONE TRIES TO REMOVE THIS CONNECTOR, THE PENTAX AIR/WATER PORT LOOSENS, AND CAN BE COMPLETELY DETACHED FROM THE ENDOSCOPE. ACCORDING TO PENTAX, FLUID INVASION CAUSED BY THIS BREACH NOT ONLY DAMAGES THE ENDOSCOPE, BUT CAN RESULT IN DEVICE MALFUNCTION AND POTENTIAL PT INJURY. REPORTER HAS BEEN TOLD BY THE PENTAX CORPORATION THAT PENTAX HAS REPEATEDLY REPORTED OTHER CUSTOMER COMPLAINTS INVOLVING THIS SAME CONNECTOR TO STERIS, AND HAS REQUESTED THAT STERIS TAKE ACTION TO PREVENT RE-OCCURRENCES. IT IS THEIR UNDERSTANDING THAT STERIS HAS NOT YET TAKEN ANY CORRECTIVE ACTIONS. THIS MEDWATCH FORM IS BEING FILED IN THE EXPECTATION THAT THE FDA CAN PERSUADE STERIS TO TAKE APPROPRIATE ACTIONS TO RECTIFY THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS CORP. ENDOSCOPIC STERILIZER (AER) MLR STERIS CORP. SYSTEM 1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other PENTAX ENDOSCOPES (VARIOUS MODELS)