BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XL, 9 ARRAY, 3-5CM, 15CM

    MDR report key: 1215642 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00079
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    August 13, 2006
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT, "COULD NOT RETRACT", WAS CONFIRMED. THE DEVICE HISTORY RECORD REVIEW REVEALED NO MANUFACTURING VARIANCES RELATED TO THIS EVENT. CAUSE OF THE COMPLAINT MAY HAVE BEEN DUE TO THE SCREW ANCHOR NOT BEING ADEQUATELY SOLDERED TO THE DRIVE TUBE.

    Description of Event or Problem · 1

    NEEDLE MUST REPOSITION, THE DR WANTS TO PUSHBACK THE HOOKS INTO THE NEEDLE BUT THEY DON'T GO BACK COMPLETELY INTO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XL, 9 ARRAY, 3-5CM, 15CM ELECTROSURGICAL DEVICE GEI ANGIODYNAMICS, INC. NA 27159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other