BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE

    MDR report key: 16506138 · Received March 8, 2023

    Report

    Report Number
    9610773-2023-00687
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 6, 2023
    Report Date
    June 15, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    14042761036716
    PMA / PMN Number
    K954488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, 30°, STERILE, SINGLE USE, 12 PCS. PMA/510K: K790071/ K903323/ K951863/ K954488. RELATED PATIENT IDENTIFIERS: PATIENT IDENTIFIER (B)(6) ADDRESSES EVENT DATE (B)(6) 2023 AND PATIENT IDENTIFIER (B)(6) ADDRESSES EVENT (B)(6) 2023 THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION CONFIRMED THAT THE LOOP WAS MISSING FROM THE FORKS ON THE DISTAL; THE DISTAL END WAS OBSERVED UNDER A MICROSCOPE, THERE IS INDICATION OF BURNT MARKS AS WELL AS MELTED INSULATION ON THE FORKS; THE FORKS ARE SLIGHTLY BENT AND DEFORMED; THE SHAFT AS WELL AS THE PROXIMAL END HAVE NO INDICATIONS OF BENDS, KINKS, OR OTHER SIGNS OF DAMAGES, AND THE STABILIZING TUBE APPEARS TO HAVE NO DEFORMITIES. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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, IT IS LIKELY THAT THE CAUSE OF THE REPORTED ISSUE IS DUE TO WEAR AND TEAR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED, THAT DURING A THERAPEUTIC PROCEDURE FOR A TRANS-URETHRAL RESECTION OF PROSTATE, THE WIRE ON THE DISTAL END WAS FRAYED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734923 HF-RESECTION ELECTRODE HYSTEROSCOPE GCP OLYMPUS WINTER & IBE GMBH A22205D 1000098399 14042761036716

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown