BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    MDR report key: 2051337 · Received April 1, 2011

    Report

    Report Number
    8010047-2011-00065
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 2, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT WITHOUT SUCCESS. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. EVALUATION REVEALED THAT THE SUBJECT DEVICE HAS THE CURRENT VERSION 3 OSCILLATION BOARD. THE UNIT DISPLAYED "ER" ON THE BIPOLAR COAG DISPLAYED SCREEN AND "02" ON THE MONOPOLAR CUT DISPLAY. THE DEVICE WAS TESTED USING A NEW OSCILLATION PRINTED CIRCUIT BOARD (PCB) WITH NO ISSUE NOTED. THE ERROR HISTORY LOG SHOWED THAT THE DEVICE ALSO EXHIBITED ERROR 04 ON THE MONOPOLAR COAG DISPLAY SCREEN WHICH INDICATED THAT THE OUTPUT WAS GENERATED LONGER THAN 60 SECONDS WITHOUT AN INTERVAL OF 30 SECONDS BETWEEN OUTPUTS. THE REPORTED PHENOMENON WAS ATTRIBUTED TO A DAMAGED OSCILLATION PRINTED CIRCUIT BOARD (PCB) AND DUE TO A FORCED OUTPUT EXPIRATORY TIME. THE CUSTOMER'S OSCILLATION BOARD WAS FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER EVALUATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE, THE ELECTROSURGICAL UNIT FAILED. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED USING A DIFFERENT ELECTROSURGICAL UNIT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SURGMASTER ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1