BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1246374 · Received November 20, 2008

    Report

    Report Number
    2027111-2008-00061
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 20, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE RETURNED UNIT WAS EVALUATED AND FOUND TO FUNCTION PROPERLY. THE JAW TIP WAS ACCEPTABLE; THE JAWS WERE PARALLEL AND WITHIN DESIGN SPECIFICATIONS. NONE OF THE ORIGINAL 20 CLIPS REMAINED IN THE DEVICE. AS A PRECAUTIONARY MEASURE, THE DEVICE IS DESIGNED TO FEED AN ADD'L "HIDDEN" 21 ST CLIP IF THE LOCK-OUT MECHANISM IS OVER RIDDEN AFTER THE ACTUATION OF THE 20TH CLIP. THE REMAINING CLIP WAS FIRED OFF AND FOUND TO CONFORM TO ALL DESIGN SPECIFICATIONS. THE INVESTIGATOR WAS UNABLE TO REPLICATE THE INCIDENT AND THEREFORE, WE ARE UNABLE TO DETERMINE A ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE. THIS REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "THE SURGEON WOULD SQUEEZE THE HANDLE TO FIRE A CLIP BUT THE CLIPS WOULD REMAIN OPEN. THE CLIPS DO NOT FORM PROPERLY ON TISSUE. PT WAS TAKEN BACK TO THEATRE FOR LAPAROTOMY IN 2008, FOR BILE LEAKAGE. PT ALIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CORP. CA090 1067006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention