BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1200389 · Received October 15, 2008

    Report

    Report Number
    2027111-2008-00056
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 15, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ABSENCE OF THE INCIDENT DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE AND FAILURE MODE. WE HAVE REVIEWED THE DEVICE HISTORY RECORD OF THIS DEVICE AND FOUND NO DEVIATIONS OR DISCREPANCIES IN OUR STANDARD MANUFACTURING AND TESTING PROCEDURES. AS A RESULT WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS INCIDENT FILE. THIS DOCUMENT SERVES AS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "DURING LAP CHOLE, DOCTOR SKELETONIZED AND IDENTIFIED CYSTIC DUCT. WHEN ATTEMPTING TO PLACE THE CLIP AROUND THE CYSTIC DUCT, THE CLIP FELL OUT OF THE JAWS OF THE CLIP APPLIER. ANOTHER CLIP WAS LOADED AND PLACED ON DUCT WITH NO ISSUES. THREE MORE CLIPS WERE PLACED ON. AGAIN, AS THE DOCTOR WAS CLOSING THE JAW, THE CLIP FELL OFF HALF WAY AND THE CLIP WAS NOT ABLE TO CLOSE CORRECTLY. PATIENT IS FINE. CLIP FELL OFF THE JAWS AND INTO THE PATIENT. DOCTOR HAD TO FIND THE CLIP AND RETRIEVE IT FROM INSIDE THE PATIENT LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CA090 1066944

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention