BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1062786 · Received June 17, 2008

    Report

    Report Number
    9610773-2008-00022
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 2008
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED TO RETURN THE DEVICE AND DEVICE FRAGMENT TO OLYMPUS FOR INVESTIGATION. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. OLYMPUS IS CURRENTLY WORKING WITH THE USER FACILITY TO INVESTIGATE THE REPORT. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE, A PORTION OF THE "CERAMIC PROTECTOR BEAK" OF THE CYSTOSCOPE OBTURATOR DETACHED FROM THE RESECTION SHEATH FELL INTO THE PATIENT'S BLADDER. THE HOSPITAL REPORTED THAT THE DEVICE FRAGMENT WAS IMMEDIATELY RETRIEVED, THE PATIENT'S BLADDER IRRIGATED, AND NO COMPLICATIONS OR ADVERSE EFFECTS WERE EXPERIENCED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH THE SAME DEVICE AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION SHEATH FED OLYMPUS WINTER & IBE GMBH A22041A 46W-0023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK