BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE

    MDR report key: 17790891 · Received September 21, 2023

    Report

    Report Number
    3003724334-2023-00041
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 25, 2023
    Report Date
    June 21, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761051665
    PMA / PMN Number
    K100275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. THE EVENT LIKELY OCCURRED DUE TO USAGE-RELATED WEAR AND TEAR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610773.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS ABLE TO BE CONFIRMED. DURING THE DEVICE EVALUATION IT WAS OBSERVED THAT THE LOOP ELECTRODE PART WAS BROKEN. IT WAS FURTHER OBSERVED THAT THE AREA AROUND THE FRACTURE WAS CHARRED, AND THE FRACTURED EDGE WAS MELTED AND SPHERICAL. THE PROBABLE CAUSE OF THIS OCCURRENCE IS THE CLOSE CONTACT OF THE BROKEN LOOPED ELECTRODE PART COMING INTO CONTACT WITH OTHER METAL PARTS, CAUSING SPARKS AND MELTING THE WIRE. THE ATTRIBUTING FACTOR TO THIS OCCURRENCE WOULD BE DUE TO HANDLING. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. RELATED COMPLAINT (SECOND ATTEMPT ELECTRODE USED): (B)(4), HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE, 12 PCS., FOR TURIS, LOT NUMBER 1000110528. ADDITIONAL PMA/510(K) NUMBER: K120418.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE, 12 PCS., FOR TURIS ELECTRODE AT THE TIP OF THE LOOP BROKE. THIS PHENOMENON OCCURRED TWICE PRIOR TO RESOLUTION. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595092 HF-RESECTION ELECTRODE ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FAS OLYMPUS WINTER & IBE GMBH WA22302D 1000110528 14042761051665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown