BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 3082813 · Received April 24, 2013

    Report

    Report Number
    8010047-2013-00098
    Event Type
    Other
    Date Received
    April 24, 2013
    Date of Event
    November 27, 2012
    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 THE 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 TIME 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, 00099, 00100 AND 00101 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, "CERVICOTOMY WITH COLLINS BLADE AND BIPOLAR RESECTION OF A PROSTATE HYPERTROPHY. AFTER REMOVAL OF THE BLADDER CATHETER IN THE POSTOPERATIVE PERIOD, THE PT SUFFERED SEVERAL EVENTS OF ACUTE URINARY RETENTION WHICH REQUIRED RECATHETERISATION, WITH MICTURITION DIFFICULTIES AFTER WITHDRAWAL. IN THE FOLLOWING WEEKS, THE PT DEVELOPED AN INFLAMMATORY REACTION ALONG THE ENTIRE LOWER URINARY TRACT WITH PROGRESSIVE SPONGIOFIBROSIS OF THE URETHRAL CORPUS SPONGIOSUM, PREVENTING MICTURITION DUE TO STRICTURE OF THE ENTIRE LENGTH OF THE URETHRA AND PRESENCE OF LOW-CAPACITY RETRACTED BLADDER. CONSEQUENCES FOR THE PT: NEED FOR INDWELLING CATHETER FOR URINARY DIVERSION, PENDING SURGICAL SOLUTION. FURTHERMORE, HAS PENILE INCURVATION DURING ERECTION ASSOCIATED WITH PENILE URETHRAL SPONGIOFIBROSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175853 OLYMPUS ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORP. UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other