BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6145928 · Received December 5, 2016

    Report

    Report Number
    9612501-2016-01022
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 9, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAP GASTRIC BYPASS, THE SUTURE AND NEEDLE CAME OFF THE DEVICE. NOTHING LEFT BEHIND, EVERYTHING RETRIEVED. NEEDLE AND SUTURE FELL INTO PATIENT CAVITY, BOTH WERE RECOVERED. ANOTHER DEVICE WAS OPENED TO CORRECT THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796201 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6E2470X

    Patients

    Seq Age Sex Outcome Treatment
    1 SUTURING SULU