BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, ROLLER

    MDR report key: 16833600 · Received April 28, 2023

    Report

    Report Number
    9610773-2023-01171
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 21, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761051719
    PMA / PMN Number
    K100275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, THE DEVICE EVALUATION, AND CORRECTION TO G2. PLEASE SEE UPDATES TO G2, H3, H6 AND H10. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE WIRE AT THE DISTAL END IS BROKEN ON BOTH SIDES AND THE ROLLER IS DETACHED FROM THE WIRE. THE PROXIMAL END DOES NOT SHOW ANY DEVIATION. 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, IT¿S LIKELY THE DEVICE WAS DAMAGED DUE TO WEAR AND TEAR. PLEASE NOTE THAT THE LOOP AT THE DISTAL END MIGHT WEAR DURING USE AND CAN BREAK, BURN OR MELT. THE FINAL ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER. PLEASE SEE UPDATE TO B5.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K120418. MODEL:HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12 PCS., FOR TURIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH CONFIRMED THE REPORTED EVENT OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR V) PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A ROLLER ELECTRODE FELL OFF INSIDE THE PATIENT DURING A PROCEDURE. THE WA22351C WAS USED WITH AN UES-40, FOR COAGULATION FOR QUITE SOME TIME, DUE TO A BLADDER TAMPONADE. THE WIRE TO THE ROLLER BALL BURNED THROUGH AND THEREBY THE BALL DROPPED INSIDE THE PATIENT. THE BALL WAS RETRIEVED BY USING OPTIC BIOPSY FORCEPS AND THE PROCEDURE WAS ONLY PROLONGED FOR ABOUT 5-10 MINUTES. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430448 HF-RESECTION ELECTRODE, ROLLER ELECTRODES PROBES FAS OLYMPUS WINTER & IBE GMBH WA22351C 1000105653 14042761051719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ELEMENT WA22366A AND RESECTOSCOPE A22023A/A22041A.