BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE GUIDE

    MDR report key: 19804574 · Received July 23, 2024

    Report

    Report Number
    3023140882-2024-00004
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 19, 2024
    Report Date
    November 29, 2024
    Manufacturer
    QUANTUM SURGICAL SAS
    Product Code
    JAK
    UDI-DI
    03760305400048
    PMA / PMN Number
    K223758
    Removal / Correction Number
    Z-0037-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REPAIRED.

    Description of Event or Problem · 0

    AT CUSTOMER LOCATION NOT PART OF AN INTERVENTION, IT WAS OBSERVED RUST ON THE NEEDLE GUIDES 02-0027 (B)(6). NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 0

    AT CUSTOMER LOCATION NOT PART OF AN INTERVENTION, IT WAS OBSERVED RUST ON THE NEEDLE GUIDES 02-0027, (B)(6). NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963758 NEEDLE GUIDE NEEDLE GUIDE JAK QUANTUM SURGICAL SAS 02-0027 03760305400048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown