BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULAR STAPLER, 33MM DIGITAL LOADING UNIT

    MDR report key: 1299472 · Received December 11, 2008

    Report

    Report Number
    2532140-2008-00133
    Event Type
    Malfunction
    Date Received
    December 11, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K040024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CS33 STAPLER WAS DISCARDED BY THE HEALTHCARE FACILITY, AND WAS NOT RETURNED TO THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR THE LOT (PM-000215) WAS REVIEWED FOR POSSIBLE ANOMALIES WHICH MIGHT ACCOUNT FOR THE OBSERVED EVENT. THERE WERE NO NON-CONFORMANCES FOUND IN THE RECORD.

    Description of Event or Problem · 1

    THE ANASTOMOSIS CREATED BY THE CS33 STAPLER WAS INCOMPLETE; A LEAK IN THE STAPLE LINE WAS OBSERVED AFTER FIRING. THERE WERE ALSO SOME MALFORMED STAPLES. THE ANASTOMOSIS WAS THEN REINFORCED BY SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCULAR STAPLER, 33MM DIGITAL LOADING UNIT STAPLE, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS PM-000215

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR