BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, MONOPOLAR

    MDR report key: 15622052 · Received October 18, 2022

    Report

    Report Number
    9610773-2022-00480
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 15, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    UDI-DI
    04042761001656
    PMA / PMN Number
    K944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. IN A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, THE OLYMPUS REPRESENTATIVE (REP.) PROVIDED CUSTOMER THE INSTRUCTIONS FOR USE (IFU) WHICH STATED TO INSPECT THE CORD AND THAT THE USE LIFE OF THE CABLE IS ONLY ONE (1) YEAR. ACCORDING TO THE REPORT , THE CUSTOMER ONLY USE THE A0393 CORD FOR A MAX OF 1YEAR AND INSPECT THE CORDS BEFORE USE ACCORDING TO THE IFU. THE REP. IN ADDITION, INSTRUCTED THE CUSTOMER TO RETURN THE CABLE, HOWEVER, TO DATE NONE HAS RETURN. LEGAL MANUFACTURER INVESTIGATIONS: OSTE INVESTIGATION RESULTS: SINCE THE PRODUCT FOR THIS COMPLAINT WAS NOT RETURNED TO OSTE, THE INVESTIGATION IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE SERVICE BUSINESS CENTER (SBC) OLYMPUS. THE PRODUCT WAS SOLD ON 06 SEPTEMBER 2018. THE ERROR DESCRIPTION PROVIDED IS PLAUSIBLE. 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 BREAKAGE OF SINGLE OR ALL THE WIRES IN THE CABLE. IT SHOULD BE NOTED THAT THIS CAN CAUSE A VOLTAGE SPIKE AT THE DAMAGED AREA WHEN THE GENERATOR IS ACTIVATED, RESULTING IN A SPARK AND COMPLETE DISCONNECTION OF THE PLUG. IT IS EVIDENT FROM THE LOT NUMBER THAT THE CABLE WAS MANUFACTURED IN JUNE OF 2018. THIS MEANS THAT THE CABLE IS 4 YEARS OLD. IT CAN THEREFORE BE ASSUMED THAT THE CABLE WAS USED FOR LONGER THAN THE SPECIFIED 12 MONTHS. ACCORDING TO OUR INVESTIGATORS, THE CAUSE OF THE REPORTED ISSUE IS MOST LIKELY DUE TO WEAR AND TEAR IN CONNECTION WITH IMPROPER HANDLING. PLEASE NOTE: THIS IS A KNOWN ERROR, BASED ON CONDUCTED INVESTIGATIONS, IT WAS DETERMINED THAT THE CABLE MAY BE DAMAGED BY STRONG MECHANICAL STRESS OCCURRING FROM REGULAR USE, FOR EXAMPLE BY KINKING THE CABLE, WINDING IT IN A RADIUS THAT IS TOO SMALL OR BY PULLING ON THE CABLE INSTEAD OF THE PLUG. THIS MAY CAUSE INDIVIDUAL OR ALL WIRES IN THE CABLE TO BREAK, WHICH MAY RESULT IN THE DESCRIBED ERROR PATTERN. HOWEVER, IN ORDER TO REDUCE THE OCCURRENCE OF THIS ERROR PATTERN, THE PERIOD OF USE OF THE CABLE WAS LIMITED TO 12 MONTHS WITHIN THE SCOPE OF AFOREMENTIONED INVESTIGATIONS. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR DEVICE A0393 WITH LOT NUMBER 824117. THERE IS NO NON-CONFORMITY ASSOCIATED WITH THIS DEVICE WITH RESPECT TO THE DESCRIBED ISSUE. THE DHR REVIEW SHOWED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. COMMENTS: 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. 20N), 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 10CM AND WHEN PULLING OUT THE CABLE, THE PLUG SHOULD BE PULLED AND NOT THE CABLE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    COMMUNICATION WITH THE CUSTOMER, THE FOLLOWING INFORMATION CONVEYED: THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS A CYSTOSCOPY WITH CLOT EVACUATION . THE PURPOSE WAS TO USE MONOPOLAR ENERGY TO GET RID OF CLOTS IN THE BLADDER. THE PROCEDURE WAS FINISHED SUCCESSFULLY BUT NOT WITH THE MONOPOLAR CORD. ONCE THE MONOPOLAR CORD BROKE, USER SWITCHED TO BIPOLAR ENERGY. NO HARM TO THE PATIENT. CUSTOMER STATED " BUT A POTENTIAL FIRE COULD HAVE STARTED SINCE THE CORD DID SPARK WHEN IT BROKE OFF". THE BOVIE MACHINE SETTINGS WAS AT 60/60. THE FIRST TIME THIS HAPPENED WAS WITH A DIFFERENT CORD AND IT HAPPENED ON (B)(6) 2022. THE BOVIE MACHINE SETTINGS THIS TIME WAS 120/60. THE SECOND TIME IT HAPPENED WAS (B)(6) 2022. SAME PART NUMBER FOR THE CORDS, BUT TWO DIFFERENT CORDS AND TWO DIFFERENT EVENTS. CUSTOMER STATED , THEY DID NOT HAVE THE CORD FROM THE FIRST EVENT ON (B)(6) 2022. CUSTOMER STATED THEY ARE RETURNING THE CORD THAT BROKE (B)(6) 2022. ON ANOTHER FOLLOW UP FOR EVENT CLARIFICATION, COMMUNICATION WITH THE CUSTOMER AND RESPONSE RECEIVED ON NOV. 2, 2022 , CUSTOMER INFORMED AND CONFIRMED THAT THE ISSUE OCCURRED IN TWO EVENTS. CUSTOMER CONVEYED THAT IT DID HAPPEN ON TWO DIFFERENT EVENTS. THE FIRST TIME IT HAPPENED THE CORD WAS NOT SAVED, AND THEREFORE THE SERIAL NUMBER IS UNKNOWN. THE MODEL NUMBER WAS THE SAME AND IT WAS A0393. TWO EVENTS: (B)(6) 2022 ¿ MODEL A0393, SN: UNKNOWN LOT- THIS IS NOT RETURNING . (B)(6) 2022 ¿ MODEL A0393, SN: (B)(6)- THIS IS RETURNING FOR EVALUATION. THIS SUPPLEMENTAL REPORT IS FOR THE EVENT DATE OF SEPTEMBER 21, 2022 WITH KNOWN LOT NUMBER. THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION. CUSTOMER RETURNED ONE MONOPOLAR HF CABLE MODEL A0393, LOT# 824117, RETURNED WITHOUT ITS ORIGINAL PACKAGING. THE DEVICE CAME IN AS 2 BROKEN PIECES. THE ESG PLUG SIDE CONNECTOR (LARGE PIN) WAS BROKEN OFF AT ITS BOOT. VISUAL INSPECTION UNDER A MICROSCOPE FOUND CHARRED MARKS ON THE DAMAGED AREA AND INTERNAL WIRES. BOTH CONNECTOR CONTACT PINS ARE INTACT, NO LOOSENESS WHEN MANIPULATED. THE DAMAGED INTERNAL WIRES AND THE INSTRUMENT SIDE CONNECTOR PLUG PASSED THE CONTINUITY CHECK, AND SO DID THE GENERATOR SIDE. HOWEVER, DUE TO THE DAMAGED WIRES, THE HF CABLE WAS NOT CHECKED FOR THE FUNCTIONALITY. DEVICE RETURN EVALUATION HAS CONFIRMED THE REPORTED ISSUE OF "CAUTERY CORDS BURNED OFF AT THE HANDLE THAT PLUGS INTO THE GENERATOR AND SPARKED" AS DURING INSPECTION, AS NOTED, UNDER A MICROSCOPE , UPON INSPECTION FOUND CHARRED MARKS ON THE DAMAGED AREA AND INTERNAL WIRES. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS REPRESENTATIVE THAT TWO OF THE A0393 CAUTERY CORDS BURNED OFF AT THE HANDLE THAT PLUGS INTO THE GENERATOR AND SPARKED. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT HARM , NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO REPORTS FOR THE TWO CORDS THAT FAILED : REPORT WITH PATIENT IDENTIFIER (B)(6) - A0393 HF-CABLE, LOT 824117 , 1 OF 2 ). REPORT WITH PATIENT IDENTIFIER (B)(6) - A0393 HF-CABLE, LOT 824117, 2 OF 2 ). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) - A0393 HF-CABLE, LOT 824117, 2 OF 2 ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265610 HF-CABLE, MONOPOLAR CABLE, MONOPOLAR GCJ OLYMPUS WINTER & IBE GMBH A0393 824117 04042761001656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR.