BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 4251531 · Received September 3, 2014

    Report

    Report Number
    9612501-2014-00312
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LAP GASTRIC BYPASS/LAP CHOLE. DR AVERBACH REPORTED THAT THE METAL ENDOSTITCH SUTURE WILL NOT STAY WITHIN THE JAWS OF THE HAND PIECE. THE METAL SUTURE KEEPS FALLING OUT OF THE JAWS. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 250CC. THERE WAS NO DELAY OVER 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535991 ENDO STITCH 10MM SUTURING DEVICE NONE KOG COVIDIEN J3M1024X

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR