BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    MDR report key: 2102006 · Received May 19, 2011

    Report

    Report Number
    8010047-2011-00101
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THE USERS SWITCHED THE MODE TO COAG FROM AN UNKNOWN INITIAL SETTING, BUT THE SUBJECT DEVICE REPORTEDLY DID NOT PROVIDE SUFFICIENT COAGULATION. INCREASING THE POWER SETTING REPORTEDLY DID NOT RESOLVE THE BLEEDING, AND THE PATIENT WAS DESCRIBED AS A HEAVY BLEEDER. THE USERS CLAIMED TO HAVE CHANGED THE ELECTRODE, ENDOSCOPE, GENERATOR, AND FLUID FROM SALINE TO GLYCINE, USING ANOTHER COMPANY'S ENDOSCOPE AND GENERATOR TO FINISH THE PROCEDURE IN ANOTHER ROOM. USERS ALSO SWITCHED TO MONOPOLAR SETTINGS TO ACHIEVE COAGULATION. THE SUBJECT DEVICE OF THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT CONFIRM THE USER'S REPORT. THE UNIT WAS FOUND TO OPERATE APPROPRIATELY. THE CUT AND COAG OUTPUT VALUES FOR SALINE, BIPOLAR AND MONOPOLAR WERE WITHIN SPECIFICATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE HAS BEEN INSPECTED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TRANS URETHRAL RESECTION (TUR) BLADDER TUMOR REMOVAL PROCEDURE WHERE THE TUMOR WAS SAID TO BE HEAVILY VASCULARIZED, THE USERS REPORTEDLY ENCOUNTERED DIFFICULTY ACHIEVING HEMOSTASIS. THE USERS REPORTEDLY TRIED INCREASING THE SETTINGS, REPLACING THE ELECTRODE, RESTARTING THE GENERATOR, AND THEN SWITCHED OUT THE ENDOSCOPE AND GENERATOR BEING USED. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH ANOTHER COMPANY'S ENDOSCOPE AND GENERATOR IN A DIFFERENT ROOM. THERE WAS NO REPORT OF PATIENT HARM, HOWEVER THE USERS REPORTED THAT THE PROCEDURE HAD BEEN DELAYED FOR 10-15 MINUTES WHILE THEY WERE ATTEMPTING TO TROUBLESHOOT THE SETUP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS (B)(4) ELECTRODES: LOT NUMBERS UNKNOWN| VALLEY LAB GENERATOR: MODEL# UNK, SERIAL# UNK| STORZ ENDOSCOPE: MODEL# UNK, SERIAL# UNK