BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT

    MDR report key: 5614283 · Received April 28, 2016

    Report

    Report Number
    5614283
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    March 30, 2016
    Report Date
    April 21, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    PKE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED GRASPER IN THROUGH TROCAR TO USE ON A LAPAROSCOPIC CHOLECYSTECTOMY. WHEN SURGEON OPENED GRASPER TO USE THE WORKING SIDE BROKE OFF AND FELL INTO ABDOMEN. PIECE RETRIEVED, NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270791 JARIT RETRACTOR, SELF-RETAINING PKE INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR