BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO SURGICAL INC.

    MDR report key: 21819992 · Received April 10, 2025

    Report

    Report Number
    3008770252-2025-00001
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    February 14, 2025
    Report Date
    April 10, 2025
    Manufacturer
    NOVO SURGICAL INC.
    Product Code
    HNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG # (B)(6) WAS SOLD TO END USER FACILITY ON 28-OCT-2022. BROKEN PIECE(S) WERE RETRIEVED WITH NO INJURY TO PATIENT REPORTED. MANUFACTURER INVESTIGATED COMPLAINT PER ITS QMS PROCESS. DHR REVIEW WAS CONDUCTED; MANUFACTURING AND RECEIVING RECORDS SHOWED NO NON-CONFORMITIES. RELEVANT TEST RECORDS INCLUDE INSULATION THICKNESS, HIPOT AND HARDNESS. THE USER FACILITY WAS REPEATEDLY CONTACTED TO REQUEST RETURN OF THE DEVICE AS WELL AS ADDITIONAL INFORMATION WITH REGARD TO ITS USE AND HISTORY. HOWEVER, ITEM WAS NOT RETURNED BY END USER FACILITY FOR EVALUATION AND NO FURTHER DETAILS ON USE OR MAINTENANCE PRACTICES WERE PROVIDED. MANUFACTURER HAD ITEMS FROM SAME PRODUCTION LOT # IN STOCK AND CONDUCTED VISUAL INSPECTION AND HIPOT TESTING ON THAT INVENTORY, WITH NO NON-CONFORMITIES NOTED.

    Description of Event or Problem · 0

    THE END USER FACILITY REPORTED THAT THE BLUE INSULATED PART OF THE INSTRUMENT "CHIPPED OFF" WHEN IT WAS USED TO RETRACT THE PATIENT'S EYELID, AND THAT THE DOCTOR WAS ABLE TO RETRIEVE BROKEN PIECES FROM THE PATIENT SCLERA WITHOUT HARM. THE DEVICE AND ANY RELATED MAINTENANCE/SERVICE INFORMATION WAS NOT MADE AVAILABLE BY END USER FACILITY FOR MANUFACTURER'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742439 NOVO SURGICAL INC. INSULATED DESMARRES LID RETRACTOR HNI NOVO SURGICAL INC. OP7116-23NC L2/18

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female