BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1172735 · Received September 15, 2008

    Report

    Report Number
    2027111-2008-00042
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 11, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INSPECTION OF THE RETURNED UNIT REVEALED THAT THE JAWS WERE PARALLEL AND THE JAW GAP WITHIN SPECIFICATIONS. THE 3 CLIPS REMAINING IN THE UNIT WERE FIRED AND CLIP CLOSURE WAS WATCHED DURING TRIGGER ACTUATION. ALL CLIPS FED, STAGED AND CLOSED PER SPECIFICATIONS. WE HAVE REVIEWED THE MANUFACTURING RECORDS OF LOT 166010; NO UNUSUAL EVENT OCCURRED DURING CONSTRUCTION. OUR INVESTIGATOR WAS UNABLE TO REPLICATE THE USER'S EXPERIENCE. WE COULD NOT IDENTIFY A ROOT CAUSE OF THE INCIDENT; THE RETURNED DEVICE FUNCTIONED PROPERLY AND CONFORMED TO ALL DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    "DR FIRED 5-6 CLIPS WITHOUT ANY PROBLEM; THE NEXT CLIP THAT LOADED INTO THE JAW FELL OUT OF THE JAW BEFORE THE SURGEON HAD AN OPPORTUNITY TO PULL THE HANDLE. THE CLIP FELL INTO THE ABDOMEN OPEN AND COULD NOT BE FOUND. A C-ARM WAS USED FOR 40 MINUTES TO SEARCH FOR THE CLIP THAT FELL INTO THE ABDOMINAL CAVITY. THE CLIP COULD NOT BE RETRIEVED BUT COULD BE SEEN UNDER FLOROSCOPY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CA090 1066010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization