BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESCULAP GRASPER

    MDR report key: 8645787 · Received May 24, 2019

    Report

    Report Number
    MW5086909
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 22, 2019
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS GOING TO GRASP FEMORAL HEAD WITH FEMORAL HEAD GRASPER, AND ONE SIDE OF THE GRASPER SNAPPED OFF WHEN GRASPING FEMORAL HEAD IN HIP CAVITY. HANDLE AND PIECE RETRIEVED AND MATCHED UP TO MAKE SURE ALL WERE ACCOUNTED FOR. INSTRUMENT PIECES PASSED OFF STERILE FIELD AND PLACED IN BIOHAZARD BAG. MANAGER CONTACTED AND GIVEN THE INSTRUMENT CONFIRMING WITH HER THE PIECE MATCHED THE HANDLE AND ALL WERE ACCOUNTED FOR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436269 AESCULAP GRASPER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH AESCULAP IMPLANT SYSTEMS, LLC MD455

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR