BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 3082811 · Received April 24, 2013

    Report

    Report Number
    8010047-2013-00101
    Event Type
    Other
    Date Received
    April 24, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 28, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT, BUT WITH NO RESULT. OLYMPUS CHECKED THE SUBJECT DEVICE AND FOUND THE ERROR02 WAS DISPLAYED AT THE FRONT PANEL AND NO OUTPUT PROVIDED. AFTER CHANGING AND OSCILLATION BOARD OF THE DEVICE, THE SUBJECT DEVICE WORKED PROPERLY. THE CAUSE OF THE ERROR WAS IDENTIFIED AS THE DEFECT OF THE BOARD. OLYMPUS ALSO CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THE SOURCE OF THE DAMAGE OF THE BOARD LIKELY WAS OPERATING THE DEVICE BEYOND RECOMMENDED ENERGY DELIVERY INTERVAL. THE UES-40 INSTRUCTIONS FOR USE ADVISES USERS, "CAUTION: THE MAXIMUM OUTPUT THE SHOULD BE 10 SECONDS AND THERE SHOULD BE AN INTERVAL OF 30 SECONDS BETWEEN OUTPUTS. THERE WAS NO INFO WHICH THE SUBJECT DEVICE WAS RELATED WITH THE PT INJURY BECAUSE THE DATE OF OCCURRENCE OF THE ERROR HAD NOT BEEN RECEIVED. UES-40 HAS A FUNCTION THAT THE ERROR02 DISPLAYS AT THE FRONT PANEL AND OUTPUT STOPS WHEN THE BOARD HAS FAULT AND INTENDED OUTPUT IS NOT PROVIDED. THEREFORE, OLYMPUS CONSIDERED THAT NORMAL OUTPUT HAD BEEN PROVIDED DURING THE PROCEDURE UNTIL ERROR02 WAS DISPLAYED. THE EXACT CAUSE OF THE PT INJURY COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER COMMON COMPLICATION OF TUR PROCEDURE CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. IF FURTHER SIGNIFICANT ADD'L INFO IS OBTAINED, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. CROSS-REFERENCE MFR. REPORT # 8010047-2013-00097, 00098, 00099 AND 00100 FOR OTHER RELATED REPORTS.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED AN INCIDENT USING THE UES-40 FROM A FACILITY IN (B)(6) THAT STATED, "AFTER COMPLETION OF SURGERY (TUR OF BLADDER TUMOUR) AND DURING CATHETERIZATION, ERYTHEMA WITH DE-EPITHELIALIZATION OF THE URETHRAL MEATUS WAS OBSERVED. IN THE POST-OPERATIVE PERIOD, IT HAS NOT BEEN POSSIBLE TO REMOVE THE BLADDER CATHETER DUE TO SEVERE MUCOSAL INFLAMMATION AND URETHRAL STRICTURE. IN AN URETHROCYSTOSCOPY PERFORMED SUBSEQUENTLY, SEVERE STRICTURE WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE URETHRA WITH ABUNDANT FOCI OF NECROTIC TISSUE ADHERED TO THE BLADDER WALL WERE ALSO OBSERVED. IN THE POST-OPERATIVE PERIOD, IT HAS NOT BEEN POSSIBLE TO REMOVE THE BLADDER CATHETER DUE TO SEVERE MUCOSAL INFLAMMATION AND URETHRAL STRICTURE. IN AN URETHROCYSTOSCOPY PERFORMED SUBSEQUENTLY, SEVERE STRICTURE WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE URETHRA WITH ABUNDANT FOCI OF FIBRINOID NECROSIS IN THE URETHRA. MULTIPLE FOCI OF NECTROTIC TISSUE ADHERED TO THE BLADDER WALL WERE ALSO OBSERVED. CONSEQUENCES FOR THE PT: PENDING A FINAL SURGICAL DECISION, MULTIPLE BLADDER CATHETERIZATIONS HAVE BEEN REQUIRED TO ACHIEVE URINE DRAINAGE THROUGH THE LOWER URINARY TRACT, AS THE PT HAS NO SPONTANEOUS MICTURITION DUE TO URETHRAL STRICTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177517 OLYMPUS ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORP. UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other