BEUDAMED
    FDA Adverse Event Other Summary report: N

    RICHARD ALLEN SURGICAL NEEDLE

    MDR report key: 2990035 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00022
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    January 5, 2011
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN NEEDLE SAMPLES WERE SUBJECT TO A MICRO-HARDNESS TEST AND VICKER'S HARDNESS TEST. VISUALLY INSPECTED AS WELL. SAMPLES PASSED HARDNESS TESTS WITH NO FAILURE. VISUAL INSPECTION SHOWED THAT THE NEEDLE HAD EXCESSIVE GRIPPING MARKS (HEAVY CUTS INTO THE SURFACE) FROM HOLDING DEVICE (FORECEPS) ON BOTH SEGMENTS OF THE NEEDLE. SUBJECTED TO SEVERE MECHANICAL DAMAGE.

    Description of Event or Problem · 1

    SURGEON SUTURING SHOULDER NEEDLE BROKE OFF IN PT. SURGEON WAS ABLE TO RETRIEVE BROKEN PIECE FROM PT'S BODY. NEEDLE BROKE IN THE MIDDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75451 RICHARD ALLEN SURGICAL NEEDLE EYED SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, INC. 2015-06-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other