BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000229

    MDR report key: 22737162 · Received August 7, 2025

    Report

    Report Number
    22737162
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 29, 2025
    Report Date
    July 30, 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

    A LASER FIBER WIRE BROKE OFF INSIDE OF THE PATIENT'S RIGHT KIDNEY. AFTER SPEAKING WITH THE SURGEON ABOUT IT, HE FELT THAT NO OTHER INTERVENTION WAS NECESSARY INCLUDING AN XRAY. HE SAID THE REASON HE FELT AN X-RAY WAS UNNECESSARY WAS BECAUSE "LASER FIBER TIPS ARE NON DETECTABLE THROUGH X-RAY". SURGEON ALSO STATED THAT AFTER LOOKING IN THE PATIENT'S URETER AND KIDNEY THAT THE FIBER WAS UNDETECTABLE AND "DID NOT SEE IT IN ORDER TO RETRIEVE IT". UPON FURTHER CONVERSATION, SURGEON DID STATE THAT HE WOULD "INFORM THE PATIENT OF WHAT HAPPENED" REGARDING THE FIBER WIRE TIP. THIS IS NOT THE FIRST TIME LASER FIBER WIRE TIPS OF THIS PARTICULAR BRAND AND BATCH HAVE BROKEN OFF DURING SURGICAL PROCEDURES. TIP OF THE FIBER WHILE IT WAS INSERTED THROUGH THE SCOPE. TIP OF THE FIBER BROKE WHILE RUNNING UP THE SCOPE. THE FIBER WAS STILL USEABLE. SETTINGS: ENERGY: 0.3J, FREQUENCY: 50HZ, POWER: 24W.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531163 8000229 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000229 DE25029 00816469021315

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male