BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6116664 · Received November 21, 2016

    Report

    Report Number
    9612501-2016-00938
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. THE NEEDLE FELL OUT OF THE DEVICE DURING THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769722 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6H2304X

    Patients

    Seq Age Sex Outcome Treatment
    1