BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS HF CABLE

    MDR report key: 2538486 · Received April 6, 2012

    Report

    Report Number
    9610773-2012-00016
    Event Type
    Other
    Date Received
    April 6, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 8, 2012
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE INFO REGARDING THE REPORT, AND WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE WORKING ELEMENT AND THE HIGH FREQUENCY CABLE WAS BURNED AND MELTED. THE USER FACILITY REPORTED THAT THEY WERE USING A NON-OLYMPUS ELECTRODE, WHICH LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO PT INJURY REPORTED, AND THE PROCEDURE WAS COMPLETED USING DIFFERENT EQUIPMENT. THE USER FACILITY RETURNED THE WORKING ELEMENT AND HIGH FREQUENCY CABLE TO OLYMPUS FOR EVALUATION. BOTH DEVICES WERE RECEIVED IN A BIOHAZARD CONTAINER INDICATING THAT BOTH DEVICES WERE CLEANED BUT NOT STERILIZED. THE EVALUATION WAS THEN LIMITED TO VISUAL INSPECTION ONLY. THE EVALUATION FOUND EVIDENCE OF THERMAL DAMAGE IN THE TEFLON BODY AT THE CONNECTION POINT BETWEEN THE WORKING ELEMENT AND HIGH FREQUENCY CABLE. THE CONNECTION PLUG THAT CONNECTS TO THE TEFLON/MAIN BODY OF THE WORKING ELEMENT WAS MELTED. THE USER'S EXPERIENCE WAS LIKELY DUE TO THE USE OF THE NON-OLYMPUS ELECTRODE. THE DEVICE INSTRUCTION MANUAL WARNS "USE ONLY HF RESECTION ELECTRODES FROM OLYMPUS. THESE ARE PRODUCED USING SPECIAL MANUFACTURING PROCESSES. THERE IS A RISK OF INJURY TO THE PT AND/OR USER WHEN USING OTHER ELECTRODES." THIS MEDICAL DEVICE REPORT IS BEING FILE IN AN ABUNDANCE OF CAUTION. CROSS REFERENCE MFR REPORT# 9610773-2012-00015 FOR A RELATED REPORT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE WORKING ELEMENT WAS BURNT UP AND MELTED IN A PT. THERE WAS NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HF CABLE CABLE KNS OLYMPUS WINTER & IBE GMBH A00012A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATALOG # SB240N| LOT NUMBER 47W0033| OLYMPUS WORKING ELEMENT: MODEL A22061A,| UNIVERSAL ROLLERBALL ELECTRODE: MODEL 111025,