BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPIC GRASPER RESUABLE SURGICAL ISNTRUMENT

    MDR report key: 18613905 · Received January 31, 2024

    Report

    Report Number
    18613905
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    September 21, 2023
    Report Date
    October 12, 2023
    Manufacturer
    DE SOUTTER MEDICAL LTD
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SURGEON WAS TRYING TO REMOVE OLD ANCHORS AND THE TIP OF THE ARTHROSCOPIC GRASPER BROKE OFF IN THE PATIENTS LEFT SHOULDER. THE INSTRUMENT WAS REMOVED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415350 ARTHROSCOPIC GRASPER RESUABLE SURGICAL ISNTRUMENT LXH DE SOUTTER MEDICAL LTD 424-122-123

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Male