BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1047988 · Received May 16, 2008

    Report

    Report Number
    2027111-2008-00017
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    March 29, 2008
    Report Date
    May 13, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION SUMMARY: TWO USED CLIP APPLIERS WERE RETURNED. THE FIRST SAMPLE, LOT 1053512, HAD 16 CLIPS REMAINING, ALL OF WHICH WERE SUCCESSFULLY FIRED. THE SECOND SAMPLE, FROM LOT 1055630, HAD SIGNIFICANT DAMAGE AT THE JAWS. ONE OF THE TWO JAW HALVES HAD BEEN BENT INWARD WHICH REDUCED THE SPACE BETWEEN THE TWO JAWS BY HALF. UNDER THESE CONDITIONS, THE DEVICE CANNOT FUNCTION. A REVIEW OF THE MFG RECORDS FOR BOTH LOTS REVEALED NO UNUSUAL EVENTS DURING CONSTRUCTION; ALL DEVICES HAD PASSED ALL INSPECTION CRITERIA INCLUDING TEST FIRING 2 CLIPS BEFORE RELEASE TO INVENTORY. THE SOURCE OF THE DAMAGE TO THE JAW OF SAMPLE 2 REMAINS UNDETERMINED. ADD'L LOT #1053512.

    Description of Event or Problem · 1

    "BILE LEAKS POST-OP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GCJ APPLIED MEDICAL RESOURCES CA090 1055630

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention