BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGASSIST CIRCULAR STAPLER 21MM DLU

    MDR report key: 744800 · Received June 15, 2005

    Report

    Report Number
    2532140-2005-00040
    Event Type
    Malfunction
    Date Received
    June 15, 2005
    Date of Event
    May 10, 2005
    Report Date
    June 9, 2005
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAP GBP PROCEDURE. CS21 DLU CUT BUT STAPLES DID NOT SECURE THE ANASTOMOSIS. STAPLES WERE FIRED BUT APPEARED TO NOT HAVE REACHED THE ANVIL POCKET. STAPLES WERE NOT B-SHAPED. THE ANVIL APPEARED TO BE SECURELY ATTACHED AND THE PC DISPLAYED "IN FIRING RANGE." MANUAL SUTURES WERE USED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGASSIST CIRCULAR STAPLER 21MM DLU SURGICAL STAPLER (IMPLANTABLE STAPLE) GDW POWER MEDICAL INTERVENTIONS NA LC-000311

    Patients

    Seq Age Sex Outcome Treatment
    1 *