BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, BIPOLAR

    MDR report key: 14651804 · Received June 10, 2022

    Report

    Report Number
    9610773-2022-00212
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    June 2, 2022
    Report Date
    October 14, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    04042761076449
    PMA / PMN Number
    K120418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE HF-CABLE HAD BROKEN OFF FROM ONE OF THE WORKING ELEMENT CONNECTORS AND THAT THE WIRES AT THE OTHER SIDE OF THE CABLE WERE ALSO BROKEN. IN THE COURSE OF TIME, ONE OR MORE WIRES INSIDE THE CABLE CAN BREAK DUE TO PERMANENT BENDING/TENSILE STRESS, AS WELL AS WEAR AND TEAR. WHEN ACTIVATING THE GENERATOR, A VOLTAGE FLASHOVER AT THE DAMAGED AREA MIGHT OCCUR. THIS VERY LIKELY CAUSES A SPARK AND THE SEPARATION OF THE PLUG. SINCE THE CABLE WAS MANUFACTURED IN DECEMBER 2016, THE CAUSE FOR THE DAMAGE IN THE CASE AT HAND IS MOST LIKELY IMPROPER HANDLING IN COMBINATION WITH WEAR AND TEAR AS WELL AS END-OF LIFE PROBLEM. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO USE ERROR. FURTHERMORE, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE BIPOLAR HF-CABLE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS, BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT APPROX. 30 MINUTES INTO A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ESG-400 HF-GENERATOR ISSUED AN "INSUFFICIENT CONDUCTIVITY" ERROR MESSAGE. THE ERROR WAS CLEARED AND THE PROCEDURE CONTINUED NORMALLY. A SHORT TIME AFTERWARDS THERE WAS A BANG AND A SPARK / FLASH FROM WHERE THE HF ABLE CONNECTED TO THE WORKING ELEMENT OF THE RESECTOSCOPE. AT THIS TIME THE SURGEON ALSO RECEIVED A SHOCK THROUGH HIS HAND, AND POSSIBLY ALSO A VERY SMALL BURN, WHICH, HOWEVER, DID NOT REQUIRE ANY MEDICAL TREATMENT. UPON INSPECTION OF THE INSTRUMENT THE HF CABLE HAD BROKEN OFF FROM ONE OF THE WORKING ELEMENT CONNECTORS. THE SURGEON'S GLOVE ALSO HAD A SMALL CHARRING MARK AND AN APPROX. 1CM SPLIT AT THE SAME POINT. THE SURGEON CHANGED HIS GLOVES AND USED ANOTHER HF CABLE TO COMPLETE THE INTENDED PROCEDURE WITH NO FURTHER ISSUES. THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420935 HF-CABLE, BIPOLAR HF-CABLES FAS OLYMPUS WINTER & IBE GMBH WA00014A 16ZW 04042761076449

    Patients

    Seq Age Sex Outcome Treatment
    1 Male OLYMPUS ESG-400 HF-GENERATOR (WB91051W)| OLYMPUS WORKING ELEMENT (WA22367A)| UNSPECIFIED OLYMPUS PLASMA RESECTOSCOPE