BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

    MDR report key: 17074145 · Received June 6, 2023

    Report

    Report Number
    9610773-2023-01561
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 9, 2023
    Report Date
    September 13, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761068236
    PMA / PMN Number
    K120418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: D9 (DATE RETURNED), G2 (ADDED SELECTION AND HEALTH PROFESSIONAL SHOULD NOT BE SELECTED ON THE INITIAL). THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE, WRONG/IMPROPER HANDLING, AND/OR USER ERROR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE REFERENCED DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. THE LOOP WIRE AT THE DISTAL TIP OF THE ELECTRODE WAS SPLIT IN THE MIDDLE, DEFORMED, AND BROKEN. THE BROKEN END OF THE LOOP WIRE WAS FOUND MELTED IN SPHERICAL SHAPE. BURN MARKS WERE OBSERVED ON THE INSULATION. A REVIEW OF THE MANUFACTURING AND QUALITY RECORDS FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT DETECTING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE HISTORY RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K100275.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HIGH FREQUENCY ELECTRODE ¿RUPTURED ON THE SECOND APPROACH¿. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES. THE CUSTOMER REPORTED THE OUTPUT SETTINGS FROM THE GENERATOR MACHINE WERE UNKNOWN. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675147 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22507D 1000101534 14042761068236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS: ESG-400 GENERATOR.