BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH POLYSORE 0 48 U/D DLU SU

    MDR report key: 2760380 · Received September 18, 2012

    Report

    Report Number
    1219930-2012-00776
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Report Date
    August 22, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SUTURE RELOAD WAS MISPLACED UPON REMOVAL OF ENDOSTITCH DEVICE DUE TO NEEDLE CRACKING IN HALF. THE NEEDLE WAS FOUND OUTSIDE THE PT ON DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH POLYSORE 0 48 U/D DLU SU DISPOSABLE SUTURING DEVICE KOG COVIDIEN, FORMERLY US N1M0411YX

    Patients

    Seq Age Sex Outcome Treatment
    1