BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION SHEATH

    MDR report key: 3172767 · Received May 31, 2013

    Report

    Report Number
    9610773-2013-00038
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT WITH NO RESULTS. THE SUBJECT DEVICE HAS NOT BEEN YET RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED DUE TO THE ABSENCE OF THE DEVICE TO INVESTIGATE. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE SUBJECT DEVICE WAS NOT RETRACTING FULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE BLACK TIP OF THE SUBJECT DEVICE WAS BROKEN OFF, LEAVING A SMALL SHARP LIP. AN X-RAY WAS PERFORMED AND NO FOREIGN BODIES WERE NOTED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241396 OLYMPUS RESECTION SHEATH RESECTION SHEATH FAS OLYMPUS WINTER & IBE GMBH A22042A 122W-0018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK