BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 23696098 · Received December 2, 2025

    Report

    Report Number
    3008988055-2025-00015
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Report Date
    March 2, 2026
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. DEVICE WAS NOT RETURNED TO MANUFACTURER AND THE INVESTIGATION WAS CONCLUDED.

    Additional Manufacturer Narrative · 0

    THE REPORT 3008988055-2025-00015 IS BEING AMENDED TO ADD THE CORRECT THE FDA CODING FOR MEDICAL DEVICE PROBLEM, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED "GUIDEWIRE BROKE WHILE INSIDE PATIENT WHEN USING LASER. SURGEON REMOVED THE BROKEN PIECES. POTENTIAL ISSUE WITH LASER HITTING GUIDEWIRE CAUSING BREAKAGE. -------------------------------------- WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LITHOTRIPSY -------------------------------------- WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; -------------------------------------- THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555281 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC SP-4113-001 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other