BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASE ENDOSCOPIC DISCECTOMY SET

    MDR report key: 16157262 · Received January 12, 2023

    Report

    Report Number
    MW5114307
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 10, 2023
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED TO (B)(6) MEDICAL ON (B)(6) 2023 BY (B)(6) SURGERY CENTER. 'TIP BROKE OFF INSIDE THE PATIENT, DISC LEAVING BEHIND 3-5MM OF MATERIAL IT WAS DECIDED TO LEAVE IT IN AND FIND OUT MORE ABOUT THE DISC MATERIAL. A DECISION WILL BE MADE TO REMOVE OR LEAVE. THE SURGEON HAS CONTACTED A NEUROLOGIST FOR ADVICE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655853 LASE ENDOSCOPIC DISCECTOMY SET POWERED LASER SURGICAL INSTRUMENT GEX CLARUS MEDICAL, LLC. 1100-002 517416

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other