BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRIVE

    MDR report key: 1210718 · Received October 23, 2008

    Report

    Report Number
    2532140-2008-00086
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    PMA / PMN Number
    K073001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN TESTED IN THE LAB WITH A TEST CS29 THE DEVICE PERFORMED AS EXPECTED. THE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. SUMMARY: REPORTED CONDITION: CS29 ATTACHED AND CALIBRATED THE DEVICE, PLACED AND ATTACHED TO THE ANVIL THEN CLOSED TO THE 5MM STOP POSITION. THE OPEN AND CLOSE BUTTONS WERE THEN INOPERATIVE. INSTALLED NEW BATTERY AND THE INDICATOR LIGHTS DISPLAYED STEADY RED. EVAL SUMMARY: DEVICE PERFORMED DURING INSPECTION AND TEST AT PMI. ROOT CAUSE: THE CAUSE OF THE INOPERATIVE BUTTONS IS UNK, THE FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    AN IDRIVEC WAS LOADED WITH A CS29 DEVICE AND CLOSED ON TISSUE. THE IDRIVEC FAILED TO RESPOND AND OPEN THE CS29. THE CS29 WAS THEN RESECTED AND NEW ANASTOMOSIS WAS CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDRIVE STAPLER, IMPLANTABLE GDW POWER MEDICAL INTERVENTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention