BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM

    MDR report key: 3283021 · Received August 5, 2013

    Report

    Report Number
    2027111-2013-00287
    Event Type
    Malfunction
    Date Received
    August 5, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 30, 2013
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVAL. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    LAPAROSCOPIC NISSEN FUNDOPLICATION N- "DR. (B)(6) WAS USING A KEITH NEEDLE TO SUTURE THE STOMACH. HE WAS USING OUR SURGERY GRASPER TO HOLD THE NEEDLE, AND SAW THE PADDING OF THE GRASPER COME OFF. HE WAS ABLE TO RETRIEVE AND REMOVE THE ENTIRE PIECE. HE SAID HE DOES NOT BELIEVE THE NEEDLE WAS IN LATIS PAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366604 EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM NONE GCJ APPLIED MEDICAL RESOURCES CORP. C4130 NA

    Patients

    Seq Age Sex Outcome Treatment
    1