BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX

    MDR report key: 4911615 · Received July 2, 2015

    Report

    Report Number
    4911615
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 2, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING SUBTOTAL COLECTOMY SURGEON USING INSTRUMENT FROM APPLIED MEDICAL "EPIX LAPAROSCOPIC GRASPER" REF C4130 LOT 1245061 GREEN PADDING AT GRAPING PART OF INSTRUMENT FELL OFF AND INSIDE THE ABDOMINAL CAVITY. SURGEON SAW SOMETHING SMALL AND GREEN ON THE SCREEN, PULLED OUT OF PATIENT AND FOUND TO BE PADDING ON GRASPER. GRASPER AND PAD WERE REMOVED FROM THE FIELD AND SENT TO MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431374 EPIX LAPARASCOPE GCJ APPLIED MEDICAL RESOURCES CORP. C4130 1245061

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR