BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRINCESS

    MDR report key: 15760347 · Received November 9, 2022

    Report

    Report Number
    1418479-2022-00031
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 9, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FAS
    UDI-DI
    04055207048962
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC WILL NOTIFY RWGMBH (MANUFACTURER) IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    RWMIC REFERENCE COMPLAINT NO. (B)(4). ON OCTOBER 20, 2022, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDSUN MANDATORY AND VOLUNTARY REPORT # 2211900000-2022-8008 REGARDING PRODUCT ID# 46531313, LOT#21003675. DESCRIPTION OF EVENT: THE TIP OF THE LOOP (WIRE PART) NOTED MISSING, MAY HAVE DISINTEGRATED. CURRENTLY, REQUESTS FOR ADDITIONAL INFORMATION FROM THE USER FACILITY HAVE BEEN UNSUCCESSFUL. RWMIC MDR AWARENESS DATE: 20-OCT-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2951401 PRINCESS CUTTING ELECTRODE BIPO 21FR FAS RICHARD WOLF GMBH 46531313 21003675 04055207048962

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female