BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF RESECTION ELECTRODE- LOOP

    MDR report key: 6826972 · Received August 29, 2017

    Report

    Report Number
    6826972
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    February 17, 2017
    Report Date
    July 25, 2017
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    Product Code
    NLW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE PROCEDURE THE SURGEON ATTEMPTED TO REMOVE THE SCOPE. DURING REMOVAL, THE FILAMENT TIP OF THE CUTTING LOOP BECAME DISLODGED IN THE PATIENT'S BLADDER. THE SURGEON WAS ABLE TO USE THE GRASPER ON THE SCOPE TO REMOVED THE DISLODGED FILAMENT. NO FOREIGN BODY WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609202 HF RESECTION ELECTRODE- LOOP ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL NLW OLYMPUS CORPORATION OF THE AMERICAS P16Y0001

    Patients

    Seq Age Sex Outcome Treatment
    1