BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6741017 · Received July 25, 2017

    Report

    Report Number
    9612501-2017-05854
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    June 26, 2017
    Report Date
    June 28, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) PROCEDURE. THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT BUT IT WAS RETRIEVED. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521355 ENDO STITCH ENDOSCOPE AND/OR ACCESSORIES KOG DAVIS & GECK CARIBE LTD 173016 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1