BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 2452291 · Received February 9, 2012

    Report

    Report Number
    MW5024224
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    December 14, 2011
    Report Date
    February 9, 2012
    Manufacturer
    US SURGICAL - COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A TOTAL LAPAROSCOPIC HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS. WHILE USING THE ENDO STITCH AUTO SUTURE SUTURING DEVICE IT WOULD NOT REOPEN AND LOCKED WITH A STITCH. INSTRUMENT WAS REMOVED WITHOUT DIFFICULTY AND SURGERY PROCEEDED WITHOUT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN ENDO STITCH AUTO SUTURE SUTURING DEVICE OCW US SURGICAL - COVIDIEN 173016 N1K560X

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability