BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6197944 · Received December 22, 2016

    Report

    Report Number
    9612501-2016-01102
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 23, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A PROCEDURE, THE TECH WAS UNABLE TO OPEN JAWS. NO PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, PATIENT DEATH, OR LABELING / PACKAGING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848396 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6D1490X

    Patients

    Seq Age Sex Outcome Treatment
    1