BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 1513533 · Received July 10, 2009

    Report

    Report Number
    8010047-2009-00133
    Event Type
    Other
    Date Received
    July 10, 2009
    Date of Event
    June 10, 2009
    Report Date
    June 11, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY FOR FURTHER INFO REGARDING THIS EVENT. MULTIPLE ATTEMPTS WERE MADE BY PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO, BUT ONLY LIMITED ADDITIONAL INFO WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND SCRAPE AND SHEAR MARKS IN THE INSTRUMENT CHANNEL, HOWEVER, IT WAS DETERMINED THAT THESE FINDINGS WOULD NOT LIKELY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE LIGHT GUIDE TUBE WAS FOUND LEAKING DUE TO A LARGE CUT, AND DENTS AND BUCKLES WERE ALSO PRESENT ON THE LIGHT GUIDE TUBE. THERE WAS EVIDENCE OF FLUID INSIDE THE CONTROL BODY UNIT, WHICH CAUSED THE SWITCH BUTTONS TO WORK INTERMITTENTLY. THE DEVICE FAILED THE FOG TEST DUE TO MOISTURE UNDER THE OBJECTIVE LENS, AND THE DISTAL END COVER INSULATION DID NOT MEET SPECIFICATION. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST HAS BEEN DISPATCHED TO VISIT THE USER FACILITY AND PROVIDE IN-SERVICE TRAINING ON HOW TO REPROCESS AND INSPECT THE ENDOSCOPE, AS NEEDED. THE CAUSE OF THE PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED, AND INADEQUATE REPROCESSING IS LIKELY A CONTRIBUTORY FACTOR. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH FDA FORM 3500A (B)(4), WHICH STATED, "AN ERCP WAS BEING PERFORMED. MULTIPLE PRODUCTS WERE INTRODUCED INTO THE SCOPE. THEN A BALLOON WAS INTRODUCED AND A PANCREATIC STENT WAS PUSHED OUT OF THE SCOPE. THE STENT WAS LODGED IN THE SCOPE FROM A PREVIOUS PT. THE STENT ENTERED THE CURRENT PT'S DUODENUM ONLY AND WAS RETRIEVED IMMEDIATELY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA DUODENOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-160VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR COOK MEDICAL PANCREATIC STENT: UNK MODEL & LOT #| UNIDENTIFIED BALLOON: UNK MODEL & LOT #