BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION SHEATH

    MDR report key: 2319549 · Received October 21, 2011

    Report

    Report Number
    9610773-2011-00029
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 23, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE ORIGINAL REPORTER IN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT, BUT RECEIVED NO ADDITIONAL INFORMATION REGARDING THIS MATTER. THE WHEREABOUTS OF THE DEVICE ARE NOT KNOWN. THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. REVIEW OF THE COMPLAINT SYSTEM IDENTIFIED NO SIMILAR REPORTS ASSOCIATED WITH THE LOT NUMBER REFERENCE IN THIS REPORT. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. HOWEVER, OLYMPUS WILL CONTINUE TO FOLLOW UP WITH THE ORIGINAL REPORTER OF THIS EVENT AND IF ADDITIONAL AND SIGNIFICANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. OLYMPUS AMERICA INC. IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORP. GYRUS ACMI REGISTRATION NUMBERS (B)(4). (B)(4). THIS IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE, DAMAGE WAS OBSERVED ON THE INNER SLEEVE AND AN UNIDENTIFIED FOREIGN OBJECT WAS FOUND IN THE BLADDER. THE FOREIGN OBJECT WAS REMOVED WITH BIOPSY FORCEPS WITHOUT ANY COMPLICATIONS AND THE PROCEDURE WAS CANCELLED. THERE WAS UNCLEAR INFORMATION AS TO WHETHER THERE WAS ANY URETHRAL DAMAGE ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION SHEATH RESECTION SHEATH FED OLYMPUS MEDICAL SYSTEMS CORP A22040A 103W-0104

    Patients

    Seq Age Sex Outcome Treatment
    1