BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER FIBER PL

    MDR report key: 24940821 · Received April 21, 2026

    Report

    Report Number
    MW5187037
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 16, 2026
    Manufacturer
    LASER PERIPHERALS LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT SCHEDULED TO UNDERGO CYSTOURETHROSCOPY, WITH BILATERAL URETEROSCOPY AND PYELOSCOPY; WITH LASER LITHOTRIPSY INCLUDING INSERTION OF INDWELLING URETERAL STENT. INTRAOPERATIVELY FOLLOWING LEFT ORIFICE ENTRY 70 MICRON AGILITY LASER FIBER WAS USED AND THE SILICONE GLASS TIP OF THE LASER FELL OFF IN A CALYX WHICH WAS REMOVED IN IT'S ENTIRETY WITH THE END GAGE BASKET AND THEN VERIFIED WITH PYELOSCOPY AND URETEROSCOPY. UPON ENTRY TO RIGHT BRAND NEW 270 MICRON AGILITY LASER FIBER WITH A DIFFERENT LOT NUMBER WAS USED AND AGAIN THE SILICONE GLASS TIP OF THE LASER FELL OFF IN A CALYX WHICH WAS REMOVED IN IT'S ENTIRETY WITH THE END GAGE BASKET AND THEN VERIFIED WITH PYELOSCOPY AND URETEROSCOPY. THERE WAS NO PATIENT INJURY NOTED WITH THE MALFUNCTION OF THE PRODUCT. PT CODE: 4582. DEVICE CODE: 2907. REF: MW5187038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14086 LASER FIBER PL POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS LLC. DJ25004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention