BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SURGEMASTER ELECTROSURGICAL UNIT

    MDR report key: 2123551 · Received June 9, 2011

    Report

    Report Number
    8010047-2011-00119
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 11, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE SALINE CONNECTOR ON THE FRONT PANEL OF THE SUBJECT DEVICE, AND THE CONNECTOR ON THE ACTIVE CORD WERE BURNT. THE MFR HAS DETERMINED THAT THE PHENOMENON WAS CAUSED BY IMPROPER HANDLING. ADD'L CLARIFYING INFO HAS BEEN REQUESTED REGARDING THIS REPORTED EVENT. IF SIGNIFICANT ADD'L INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT TOWARD THE END OF A THERAPEUTIC TRANS URETHRAL RESECTION OF PROSTATE IN SALINE (TURPIS) PROCEDURE, THE PT COMPLAINED OF EXPERIENCING AN ELECTRIC SHOCK. THE PHYSICIAN STOPPED THE PROCEDURE. THE PT WAS SAID TO BE IN STABLE CONDITION, AND EXPERIENCED NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK WA22367A WITH SERIAL NUMBER (B)(4)| WA22302D| WA00013A| A22001A WITH SERIAL NUMBER (B)(4)| A22040A WITH SERIAL NUMBER (B)(4)| A22026A WITH SERIAL NUMBER (B)(4)