BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MMX35CM 22MM DIRECT DRIVE DISPOSABLE GRASPER

    MDR report key: 2051176 · Received April 6, 2011

    Report

    Report Number
    2027111-2011-00038
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 6, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. FOLLOW UP WILL BE PROVIDED WITHIN 90 DAYS OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    LAP NISSAN FUNDOPLICATION - "GRASPER WOULD NOT RELEASE PT'S TISSUE. BOTH RNFA AND SURGEON TRIED TO RELEASE GRASPER WITH NO SUCCESS. SURGEON HAD TO PULL GRASPER OUT OF THE PT WITH THE TISSUE STILL ATTACHED BETWEEN THE GRASPER JAWS. SURGEON NOTED A TEAR IN THE PT'S STOMACH FOLLOWING REMOVAL OF THE GRASPER." "SURGEON REPAIRED THE TEAR IN THE PT'S STOMACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MMX35CM 22MM DIRECT DRIVE DISPOSABLE GRASPER NONE GCJ APPLIED MEDICAL C4130 1124556

    Patients

    Seq Age Sex Outcome Treatment
    1 Other