BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE

    MDR report key: 1766636 · Received July 14, 2010

    Report

    Report Number
    9610773-2010-00023
    Event Type
    Other
    Date Received
    July 14, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 1, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP ON THIS REPORT AND WAS INFORMED THAT AT THE TIME OF THE PROCEDURE THE USERS HAD SEARCH IN AND AROUND THE STERILE FIELD AND DRAPES FOR THE LOOP FRAGMENT, BUT NOTHING WAS FOUND. FOLLOWING THE COMPLETION OF THE CASE, THE ELECTROSURGICAL UNIT AND BIPOLAR CORD WERE CHECKED BY THE CLINICAL ENGINEERING STAFF AND REPORTED THAT THERE WERE NO ANOMALIES FOUND AND THE CORD WERE FUNCTIONING APPROPRIATELY AND WERE RETURNED TO SERVICE. THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF THE EQUIPMENT ASSOCIATED WITH THIS REPORT IS RETURNED FOR EVALUATION. OR IF ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORPORATION, (B)(4). GYRUS ACMI REGISTRATION NUMBERS: (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A TRANSURETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE, APPROXIMATELY HALFWAY THROUGH THE PROCEDURE, THE USER NOTED THAT THE LOOP PORTION OF THE ELECTRODE HAD BROKEN OFF. A PORTION OF THE LOOP WAS OBSERVED IN THE BLADDER UNDER DIRECT VISUALIZATION. HOWEVER, WHEN THE USER ATTEMPTED TO REMOVE THE FRAGMENT, IT COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED, HOWEVER, THE RESULT WAS SAID TO BE NEGATIVE. THE PROCEDURE WAS COMPLETED WITH UNK DEVICE AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE ELECTRODE JOS OLYMPUS WINTER & IBE GMBH WA22306D 09286

    Patients

    Seq Age Sex Outcome Treatment
    1 HF CABLE: MODEL WA00013A| OLYMPUS ELECTROSURGICAL UNIT: MODEL UES-40, | RESECTOSCOPE| SERIAL # (B)(4)| HF CABLE: MODEL WA00013A| SERIAL # (B)(4)| OLYMPUS ELECTROSURGICAL UNIT: MODEL UES-40,| RESECTOSCOPE