BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000229

    MDR report key: 21976055 · Received May 7, 2025

    Report

    Report Number
    21976055
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 22, 2025
    Report Date
    April 23, 2025
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    UDI-DI
    00816469021315
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AT 0840 IT WAS TIME FOR LASER LITHOTRIPSY AND THE LASER REP, PASSED OFF THE AGILITI 272U LASER FIBER PL WITH LOT# DB25006. THE LASER FIBER BROKE, TWO PIECES BROKE OFF INSIDE THE PATIENT, TWO BROKEN PIECES WERE RETRIEVED AND BAGGED. A SECOND LASER FIBER, AGILITI 272U LASER FIBER PL ALSO WITH LOT# DB25006 WAS OPENED AND PASSED TO SURGEON. THE SECOND LASER FIBER BROKE, ONE PIECE BROKE OFF IN THE PATIENT, ONE PIECE WAS RETRIEVED AND BAGGED. A THIRD LASER FIBER, AGILITI 272U LASER FIBER PL WITH NEW LOT# DB25017 WAS OPENED AND PASSED TO SURGEON. THE THIRD LASER FIBER BROKE, ONE PIECE BROKE OFF IN THE PATIENT, ONE PIECE WAS RETRIEVED AND BAGGED. LASER SERVICES WERE DISCONTINUED. ALL FIBERS AND BROKEN PIECES WERE BAGGED AND LABLED. SURGEON REQUESTED DIFFERENT LASER MACHINE TO BE BROUGHT IN. STENT WAS PLACED AND PATIENT PROCEDURE CONCLUDED. AGILITI LASER REP, PUT IN AN INCIDENT REPORT WITH HIS COMPANY WHICH WAS TO BE SENT TO OR MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820525 8000229 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000229 DB25006 00816469021315

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male