BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    LASE ENDOSCOPIC DISCECTOMY SET

    MDR report key: 16659708 · Received March 31, 2023

    Report

    Report Number
    2183911-2023-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 18, 2023
    Manufacturer
    CLARUS MEDICAL, LLC
    Product Code
    GEX
    PMA / PMN Number
    K040424
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO CLARUS FOR EXAMINATION. THE DHR SHOWED NO ABNORMALITIES DURING MANUFACTURING AND THE DEVICE PASSED FINAL INSPECTION. AFTER REVIEWING THE RMA DATABASE, EMAIL / VERBAL COMMUNICATION WITH CUSTOMER, PICTURES PROVIDED BY CUSTOMER AND INTERNAL REVIEW OF THE LASE DESIGN, IT CAN BE CONCLUDED THAT THE DEVICE MORE THAN LIKELY HAD INADEQUATE IRRIGATION WHILE IN USE CAUSING THE DEVICE TO OVERHEAT. ADDITIONAL INFORMATION: INCIDENT WAS ORIGINALLY REPORTED USING FORM 5400 ON 10 JAN 2023. SEE ATTACHED FORM AND FDA RESPONSE. SEE MW5114307.

    Description of Event or Problem · 0

    ON (B)(6) 2023, CLARUS RECEIVED COMMUNICATION FROM (B)(6) CENTER ABOUT AN ISSUE WITH A LASE DEVICE. DURING USE, 'THE TIP BROKE OFF INSIDE THE PATIENT DISC LEAVING 3-5 MM OF MATERIAL'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534572 LASE ENDOSCOPIC DISCECTOMY SET LASE ENDOSCOPIC DISCECTOMY SET GEX CLARUS MEDICAL, LLC 1100-002 57413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other