BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6038587 · Received October 18, 2016

    Report

    Report Number
    9612501-2016-00806
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 23, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKETING VIGILANCE (PMV) RECEIVED ONE ENDO STITCH* 10MM SUTURING DEVICES, OPENED BY THE ACCOUNT WITH THE APPROPRIATE DISPLAY BOX. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE BLADES OF THE INSTRUMENT WERE BENT. THE JAW GAP WAS MEASURED AND DID NOT MEET SPECIFICATION. WITNESS MARKS ONE BEVEL WALL WERE OBSERVED. NO SHEERING WAS OBSERVED ON THE TOGGLE SWITCHES. THE BLADES WERE BENT BACK INTO PLACE. THE INSTRUMENT WAS THEN LOADED WITH A NEEDLE FROM THE POST MARKETING VIGILANCE (PMV) INVENTORY AND APPLIED TO TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS FROM BOTH SIDES OF THE JAWS DURING THIS TEST IN AN EFFORT TO SIMULATE CLINICAL CONDITIONS. THE INSTRUMENT WAS FOUND TO FUNCTION PROPERLY AND EACH NEEDLE REMAINED INTACT. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLE FOR BOTH INSTRUMENTS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE COMPONENT WAS REMOVED FROM THE PATIENT CAVITY WITH THE USE OF GRASPERS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A ROUX-EN-Y PROCEDURE, THE DEVICE WAS VERY DIFFICULT TO LOAD ONCE IT WAS OPENED FROM STERILE PACKAGING. THE NEEDLE FELL OUT OF THE JAWS AFTER PASSING THROUGH THE PATIENT'S TISSUE ONCE. THE NEEDLE WAS RECOVERED VERY CAREFULLY WITH A GRASPER INSTRUMENT AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689001 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6E1615X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR RELOAD