BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION ELECTRODE

    MDR report key: 1810636 · Received July 26, 2010

    Report

    Report Number
    9610773-2010-00025
    Event Type
    Malfunction
    Date Received
    July 26, 2010
    Date of Event
    May 27, 2010
    Report Date
    June 28, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT, BUT LIMITED INFORMATION HAS BEEN PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE SPECIFIC MODEL OF THE ELECTRODE USED DURING THE PROCEDURE WAS NOT PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE LATER, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. (B)(4): OLYMPUS AMERICA, INC. IS SUBMITTING MEDICAL DEVICE REPORT (B)(4).

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "WHILE RESECTING DURING TURP PROCEDURE USING THE OLYMPUS BIPOLAR MACHINE, THE DISPOSABLE LOOP (RESECTION ELECTRODE) BROKE OFF IN THE BLADDER. THE BROKEN OFF PORTION OF THE LOOP WAS NOT VISUALIZED. A CYSTOSCOPE WAS USED TO VISUALIZE THE BLADDER AND URETHRA; THE LOOP WAS NOT FOUND. THE SPECIMEN WAS CHECKED FOR THE LOOP, AS WELL AS THE DRAPES AND FLOOR. A PORTABLE X-RAY WAS ORDERED AND READ AS NEGATIVE. CYSTOSCOPY WAS PERFORMED ONE LAST TIME AND STILL NOTHING WAS VISUALIZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION ELECTRODE RESECTION ELECTRODE FAS OLYMPUS WINTER & IBE GMBH UNK 09286POOL001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR (B)(4), MODEL: UES-40| OLYMPUS ELECTROSURGICAL UNIT| (B)(4), MODEL: UES-40| OLYMPUS ELECTROSURGICAL UNIT