BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EMPOWER LASER FIBER

    MDR report key: 22941770 · Received September 2, 2025

    Report

    Report Number
    MW5175504
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 27, 2025
    Report Date
    August 27, 2025
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT DESCRIPTION S-DURING A UROLOGY SURGERY CASE WE OPENED A LASER FIBER TO BE USED ON THE PATIENT. ONCE THE FIBER WAS INSERTED YOU COULD SEE THE END OF THE FIBER SHEATH HAD SCRAPES OFF LEAVING THE FIBER EXPOSED. WE PULLED THAT FIBER OUT AND OPENED A SECOND ONE AND SAW THAT IT TOO WAS IN THE SAME CONDITION BUT SLIGHTLY WORSE AND A PIECE OF THE BLUE SHEATH CAME OFF IN THE PATIENT. B-LASER FIBERS ARE VERY DELICATE AND WHEN THE SHEATH IS REMOVED OR DAMAGED IT POSES A RISK TO THE PATIENT AND USER FOR POTENTIAL INADVERTENT LASER BURNS. IT IS HARD TO SEE WITH THE NAKED EYE THE DAMAGE. IT ISN'T UNTIL IT IS INSIDE THE PATIENT UNDER THE SCOPE MAGNIFICATION THAT YOU SEE THE PROBLEMS. A-AFTER WE REMOVED THE THIRD FIBER, IT WAS DISCUSSED THAT THE PATIENT WILL BE FLUSHED OUT WITH PLENTY OF FLUID THAT THE PLASTIC PIECE WILL BE WASHED OUT AND WHEN WE OPENED A 3RD LASER FIBER IT WAS FULLY INTACT PRIOR TO USE. R-REPORTED THE FAULTY FIBERS TO OLYMPUS AND INVOLVED PAD STAFF TO CONTACT COMPANY ABOUT IT. AWAITING RESPONSE FROM OLYMPUS. FIBER INFO REF# EMP-FBX272HS-C LOT# H243553. PATIENT CODE: 2687. DEVICE CODE: 1261. REFERENCE REPORT: MW5175503.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450304 OLYMPUS EMPOWER LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX QUANTA SYSTEM, S.P.A. EMP-FBX272HS-C

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male