BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS OES CYSTONEPHROFIBERSCOPE

    MDR report key: 1821220 · Received August 26, 2010

    Report

    Report Number
    9610773-2010-00027
    Event Type
    Injury
    Date Received
    August 26, 2010
    Report Date
    February 29, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY ON THIS REPORT VIA TELEPHONE AND IN WRITING TO GATHER ADDITIONAL INFORMATION, HOWEVER, ONLY LIMITED INFORMATION WAS PROVIDED. THE SUBJECT DEVICE HAD BEEN ORIGINALLY RETURNED TO OLYMPUS FOR SERVICE WITH A REPORT OF HEAVY CORROSION ON THE BENDING SECTION AND DISTAL END. THE EVALUATION HAD CONFIRMED THE USER REPORT OF HEAVY CORROSION. THE INSERTION TUBE BORE DEEP CUTS AND BLISTERS, AND THE UNIT FAILED INSULATION TESTING. THE INSTRUMENT CHANNEL WAS ALSO KINKED. THE DEVICE HAS BEEN SERVICED. AS PART OF OUR FOLLOW-UP INTO THIS REPORT, AN ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO ASSESS THE REPROCESSING PRACTICES AT THE FACILITY, AND TO PROVIDE IN-SERVICE ON HOW TO PROPERLY REPROCESS ENDOSCOPES AS NEEDED. BASED UPON THE INFORMATION PROVIDED, THE USER FACILITY WAS DETERMINED NOT TO BE REPROCESSING THE DEVICE IN ACCORDANCE TO THE DEVICE INSTRUCTION MANUAL. THE ESS TRAINED THE USER HOW TO PROPERLY REPROCESS THE SCOPE. THE CAUSE OF THE PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IMPROPER REPROCESSING OF THE DEVICE CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THIS REPORT IS BEING SUBMITTED AS AN MDR IN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC. IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORPORATION. GYRUS ACMI REGISTRATION NUMBER (B)(4). EXEMPTION NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    OCA UNDERTOOK A RETROSPECTIVE REVIEW OF ITS MDR FILES FOR THE PERIOD OF JANUARY 2005 TO APRIL 2015. BASED UPON THIS REVIEW, WE ARE SUBMITTING THIS SUPPLEMENTAL REPORT TO ACCOUNT FOR EACH OF THE SEVEN PATIENTS INVOLVED IN THIS EVENT. PLEASE CROSS REFERENCE MFR. REPORT NUMBERS: 2951238-2016-00168, 2951238-2016-00169, 2951238-2016-00170, 2951238-2016-00171, 2951238-2016-00172 AND 2951238-2016-00173.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE HAD BEEN A APPROXIMATELY SEVEN CASES OF PSEUDOMONAS INFECTIONS AFTER HAVING UNDERGONE A CYSTOSCOPY PROCEDURE WITH THE SUBJECT DEVICE. ALL OF THE PATIENTS WERE SAID TO HAVE REQUIRED ANTIBIOTICS FOR TREATMENT, AND THREE OF THE PATIENTS WERE REPORTEDLY HOSPITALIZED. THE STATUS OF THE PATIENTS IS NOT CURRENTLY KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE FAJ OLYMPUS WINTER & IBE GMBH CYF-5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization