BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1172732 · Received September 15, 2008

    Report

    Report Number
    2027111-2008-00044
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    August 24, 2008
    Report Date
    September 11, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT DESCRIBED IN THE CUSTOMER'S EXPERIENCED REPORT WAS NOT RETURNED FOR EVALUATION. ONE UNIT WAS RETURNED AND RECEIVED STERILE AND UNOPENED. UPON EVALUATION, ENGINEERING FOUND THE UNIT TO FUNCTION PROPERLY. THE JAW TIP GAP WAS ACCEPTABLE; THE JAWS WERE PARALLEL AND WITHIN DESIGN SPECIFICATIONS. THERE WERE TWENTY CLIPS REMAINING IN THE DEVICE. THE UNIT WAS FIRED DOWN AND OBSERVED DURING EACH TRIGGER ACTUATION. ALL TWENTY CLIPS FEED AND STAGED CORRECTLY INTO THE JAWS OF THE DEVICE; AS WELL AS CLOSED PROPERLY AND WERE FOUND TO BE WITHIN DESIGN SPECIFICATIONS. THE RETURNED DEVICE FUNCTIONED PROPERLY AND CONFORMED TO ALL DESIGN SPECIFICATIONS. THE EXACT CAUSE OF THIS FAILURE IS NOT KNOWN. ENGINEERING WAS UNABLE TO REPRODUCE THE RESULTS STATED BY THE CUSTOMER AND THE RETURNED UNIT CONFORMED TO ALL DESIGN SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS OF LOT 1064762 REVEALED NO UNUSUAL EVENTS DURING CONSTRUCTION; THE LOT HAD PASSED ALL QUALITY INSPECTIONS. THIS CONCLUDES OUR INVESTIGATION. THIS REPORT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "A DR. WAS PERFORMING A LAP CHOLE. IN PRIOR CASES, CLIPS WERE SCISSORING. IN THIS PARTICULAR CASE THE DOCTOR HAD PLACED SEVERAL CLIPS ON THE CYSTIC DUCT AND ARTERY. POST SURGERY LEAKAGE RESULTED IN PATIENT BEING SENT BACK TO THE O.R. SAMPLE BEING SENT BACK IS FROM THE SAME LOT #, THE PARTICULAR CLIP APPLIER WAS NOT SAVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CA090 1064762

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention