BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS UROLOGY LASER FIBER WIRE

    MDR report key: 15958871 · Received December 9, 2022

    Report

    Report Number
    MW5113715
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 7, 2022
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UROLOGY LASER FIBER WIRE TIP BROKE OFF WHEN THE CLEAR PLASTIC TIP PROTECTOR WAS REMOVED BY SCRUB TECH. LASER FIBER WIRE NEVER TOUCH PATIENT. MANUFACTURE: OLYMPUS, PRODUCT NUMBER EMP-FBX365HS, LOT NUMBER: H220206, MANUFACTURE DATE EXP:01-06/2027. LASER FIBER WIRE IS ONE TIME USE. A THIRD PARTY DOES NOT HANDLE THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420336 OLYMPUS UROLOGY LASER FIBER WIRE POWERED LASER SURGICAL INSTRUMENT GEX QUANTA SYSTEM, S.P.A. EMP-FBX365HS H220206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown