BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 24921381 · Received April 19, 2026

    Report

    Report Number
    3008988055-2026-00003
    Event Type
    Malfunction
    Date Received
    April 19, 2026
    Date of Event
    October 7, 2025
    Report Date
    April 19, 2026
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 IS CONCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED "DATE OF EVENT: 07OCT2025 CUSTOMER: (B)(6) [UNITED STATES] I [COOK SALES REP] RECEIVED A CALL FROM # C21448-85 THAT YESTERDAY DURING A CASE A SURGEON FIRED THE LASER AND LEFT BEHIND A PIECE OF THE OUTER COATING FROM THE MOTION WIRE (IT MIGHT HAVE INSTEAD BEEN A PIECE OF THE HYDROPHILIC TIP, THEY ARE NOT SURE). CUSTOMER ASKED IF IT WAS OKAY TO LEAVE THE PIECE BEHIND INSIDE THE PATIENT, AND I INFORMED THEM THAT COOK MEDICAL CANNOT APPROVE OF ANY FOREIGN BODIES LEFT BEHIND IN A PATIENT. THAT IS ULTIMATELY UP TO THE SURGEON TO DECIDE. CUSTOMER DID NOT RETAIN PACKAGING OR BROKEN PRODUCT AND PROVIDED NO PICTURES/VIDEO EVIDENCE OF THIS INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244653 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