BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION SHEATH

    MDR report key: 3960851 · Received June 27, 2014

    Report

    Report Number
    2951238-2014-00281
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT A PORTION OF THE CERAMIC BEAK AT THE DISTAL TIP OF THE RESECTION SHEATH BROKE OFF. THE DEVICE WAS SERVICED AND RETURNED TO THE FACILITY. THE DAMAGE FOUND ON THE DEVICE IS CONSISTENT WITH PHYSICAL DAMAGE. THE DEVICE INSTRUCTION MANUAL STATES: "VISUALLY INSPECT THE CERAMIC INSULATION AT THE SHEATH'S DISTAL END BEFORE EACH USE. DO NOT USE THE INSTRUMENT IN CASE OF DAMAGE (E.G. CRACKS. FRACTURES)." ALSO, WARNING STATEMENT: "IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TOWARDS THE END OF A TRANSURETHRAL RESECTION OF THE BLADDER (TURB), THE CERAMIC TIP OF THE RESECTION SHEATH BROKE OFF AND FELL INSIDE THE PT'S BLADDER. THE BROKEN TIP WAS RECOVERED FROM THE PT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376159 OLYMPUS RESECTION SHEATH RESECTION SHEATH FJL OLYMPUS WINTER & IBE GMBH A22041A 138W-0015

    Patients

    Seq Age Sex Outcome Treatment
    1