BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION SHEATH

    MDR report key: 3170660 · Received May 22, 2013

    Report

    Report Number
    9610773-2013-00037
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT AND WAS INFORMED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF THE DEVICE IS RETURNED FOR EVALUATION AND/OR 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 A TRANSURETHRAL RESECTION OF THE BLADDER TUMOR, THE GREY BEAK AT THE DISTAL END OF THE SUBJECT DEVICE BROKE OFF INSIDE THE PATIENT'S URETHRA. THE USER UTILIZED A CYSTOSCOPE AND GRASPING FORCEPS TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED BUT THE PROCEDURE WAS DELAYED 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226848 OLYMPUS RESECTION SHEATH RESECTION SHEATH FED OLYMPUS WINTER & IBE GMBH A22041A 10WY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ELECTROSURGICAL GENERATOR UES-40, SERIAL # UNK| GRASPING FORCES| CYSTOSCOPE