BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, MONOPOLAR

    MDR report key: 12970923 · Received December 9, 2021

    Report

    Report Number
    9610773-2021-00351
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    UDI-DI
    04042761001656
    PMA / PMN Number
    K944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TECHNICAL SUPPORT ENGINEER ADVISED THE CUSTOMER THAT THE CABLE HAS A ONE YEAR LIFE SPAN. AS PART OF THE INVESTIGATION, OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULTS. NO DEVICE WILL BE RETURNED. THE LEGAL MANUFACTURER PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CONCERNED DEVICE AND NO ABNORMALITIES WERE FOUND. THE INVESTIGATION WAS COMPLETED BY THE LEGAL MANUFACTURER AND DETERMINED THAT THERE IS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. HOWEVER, SINCE NO DEVICE WAS RETURNED TO THE LEGAL MANUFACTURER, THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. THE ERROR DESCRIBED IS A KNOWN ERROR PATTERN AND CAN BE CONFIRMED. THE AGE-RELATED WEAR IN CONNECTION WITH REPEATED EXTREME BENDING OR TENSILE LOADS MOST LIKELY LED TO THE BREAKING OF SINGLE OR ALL WIRES IN THE CABLE IN THE AREA OF ONE OF THE PLUGS. IT SHOULD BE NOTED THAT THIS CAN CAUSE A VOLTAGE SPIKE AT THE DAMAGED AREA WHEN THE GENERATOR IS ACTIVATED WHICH MAY RESULT IN A SPARK. IT IS EVIDENT FROM THE LOT NUMBER THAT THE DEVICE WAS MANUFACTURED IN THE YEAR 2015. IT CAN THEREFORE BE ASSUMED THAT THE CABLE WAS USED FOR LONGER THAN THE SPECIFIED 12 MONTHS. THE CAUSE OF THE DAMAGE IS THEREFORE MOST LIKELY DUE TO AGE-RELATED WEAR IN CONNECTION WITH IMPROPER HANDLING. IN GENERAL, THE CUSTOMER IS REQUIRED TO CHECK THE FUNCTION OF ALL DEVICES USED PRIOR TO A PROCEDURE. ADDITIONALLY, ACCORDING TO THE IFU, A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED DURING AN APPLICATION. IN ORDER TO AVOID SUCH INCIDENTS, THE INSTRUCTIONS FOUND IN THE INSTRUCTIONS FOR USE (IFU) SHOULD BE FOLLOWED. THIS WOULD BE, FIRSTLY, THAT THE SERVICE LIFE OF THE CABLE IS LIMITED TO 12 MONTHS. AFTER THIS TIME, THE CABLE SHOULD NO LONGER BE USED. ADDITIONALLY, THE CABLE MUST BE CHECKED FOR DAMAGE BEFORE EACH USE AND AFTER REPROCESSING. BY GENTLY PULLING ON THE PLUG (MAX. 20 NM), IT CAN BE DETERMINED WHETHER THE COPPER STRAND OF THE CABLE IS ALREADY DAMAGED. IF THE CABLE DOES NOT GIVE WAY BUT REMAINS RIGID, THE CABLE IS MOST LIKELY INTACT. IN ORDER NOT TO SHORTEN THE SERVICE LIFE OF THE CABLE ANY FURTHER, THE CABLE SHOULD NOT BE WOUND UP WITH A LOOP DIAMETER OF LESS THAN 10 CM AND WHEN PULLING OUT THE CABLE, THE PLUG SHOULD BE PULLED AND NOT THE CABLE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    THE TECHNICAL SUPPORT ENGINEER WAS INFORMED BY THE BIOMEDICAL EQUIPMENT TECHNICIAN AT THE USER FACILITY THAT THERE WAS A FIRE DURING AN UNKNOWN THERAPEUTIC PROCEDURE AND WANTED THE HIGH FREQUENCY MONOPOLAR CABLE INSPECTED. THE CUSTOMER DID NOT HAVE ANY FURTHER INFORMATION REGARDING THE INCIDENT AND IF IT WAS THE CABLE THAT CAUSED IT. NO PATIENT OR USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866152 HF-CABLE, MONOPOLAR HF MONOPOLAR CABLE GCJ OLYMPUS WINTER & IBE GMBH A0393 532678 04042761001656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown