BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS QUICK CONNECT

    MDR report key: 792093 · Received November 16, 2006

    Report

    Report Number
    1527821-2006-00003
    Event Type
    Other
    Date Received
    November 16, 2006
    Date of Event
    October 17, 2006
    Report Date
    October 31, 2006
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TO MITIGATE FUTURE OCCURRENCES OF QUICK CONNECT USE ERROR FACILITY, STERIS HAS SINCE PROVIDED THE CORRECT QUICK CONNECTS (QLC1726) FOR PROPER REPROCESSING OF THEIR OLYMPUS ENDOSCOPES ALONG WITH ADDITIONAL ON-SITE IN-SERVICE TRAINING. FACTORS MITIGATING AGAINST THE RISK OF QUICK CONNECT USE ERROR INCLUDE THE CLEAR LABELING ON THE PRODUCT, WHICH INCLUDES A QUICK REFERENCE CARD, WALL CHART, AND PROCESSING INSTRUCTIONS THAT LIST AUTHORIZED SCOPE USAGE, IN ADDITION TO IN-SERVICE TRAINING, AND SELF-TUTORIALS. THE LABELING FOR EACH STERIS QUICK CONNECT (E.G. QLC1726) CLEARLY LISTS THE APPLICABLE ENDOSCOPE MODELS IN THREE SEPARATE LABELING DOCUMENTS: THE QUICK REFERENCE CARD, THE WALL CHART, AND THE PROCESSING INSTRUCTIONS. THE LABELING FOR THE QLC1726 LISTS THE OLYMPUS ENDOSCOPE MODELS PCF-Q180AL, CF-Q180AL, AND CF-Q160AL. THE QLC1725 LABELING DOES NOT INCLUDE THE AFOREMENTIONED OLYMPUS ENDOSCOPES. HOSP HAS NOT ASSOCIATED THIS EVENT WITH ANY CLINICAL ADVERSE EVENT, BUT BECAUSE THE LEVEL OF STERILITY CANNOT BE GUARANTEED WHEN THE SYSTEM 1 AND QUICK CONNECTS ARE USED IN A MANNER INCONSISTENT WITH THEIR LABELING, STERIS IS FILING THIS MDR TO BE CONSERVATIVE SINCE NO SERIOUS INJURY HAS BEEN REPORTED.

    Description of Event or Problem · 1

    DURING A STERIS ACCOUNT MANAGER VISIT, IT WAS DISCOVERED THAT HOSPITAL STAFF WITHIN THE GI DEPARTMENT WERE USING AN INCORRECT QUICK CONNECT (QC), TO REPROCESS THREE DIFFERENT MODELS OF OLYMPUS ENDOSCOPES: PCF-Q180AL, CF-Q180AL, AND CF-Q160AL IN THE STERIS SYSTEM 1. THESE OLYMPUS ENDOSCOPES HAVE AN AUXILIARY WATER INLET PORT, AND REQUIRE QC QLC1726 THAT PROVIDES A CONNECTION TO THIS PORT/LUMEN FOR STERILANT FLOW DURING REPROCESSING IN SYSTEM 1. THE CUSTOMER INCORRECTLY USED QC QLC1725 THAT DOES NOT HAVE A CONNECTION FOR THIS PORT. BASED UPON THEIR INVESTIGATION, HOSP ESTIMATES THAT THEY HAVE USED THE INCORRECT QC TO REPROCESS THESE GI DEVICES FOR SEVERAL MONTHS. HOSP ALSO INDICATES THAT THEY HAVE USED THE SYSTEM 1 TO REPROCESS THE WATER SUPPLY TUBES FOR THESE ENDOSCOPES, AN ACCESSORY THAT STERIS HAS NOT VALIDATED FOR REPROCESSING IN SYSTEM 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS QUICK CONNECT MEDICAL DEVICE ACCESSORY MLR STERIS CORPORATION QLC1725 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other