BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6016879 · Received October 11, 2016

    Report

    Report Number
    9612501-2016-00738
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 13, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SUTURING DEVICE OPENED BY THE ACCOUNT. 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. A NEEDLE WAS RECEIVED. THE VISUAL INSPECTION OF THE SUTURING DEVICE NOTED WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL SURROUNDING THE NEEDLE RECEPTACLE. THE VISUAL INSPECTION OF THE NEEDLE NOTED WITNESS MARKS AROUND THE LOADING SLOT AND CONES. AFTER FURTHER VISUAL INSPECTION, SOME PLASTIC SHEARING WAS NOTED ON THE TOGGLE SWITCH. A PMV NEEDLE WAS LOADED ONTO THE DEVICE. THE NEEDLE WAS FOUND TO FUNCTION PROPERLY WHEN APPLIED THROUGH LAYERS OF TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS AND FROM BOTH SIDES OF THE JAW TO SIMULATE CLINICAL CONDITIONS. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE FILE WAS CONCLUDED TO BE A MISUSE OF THE PRODUCT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RECEIVED FOR EVALUATION. DEVICE EVALUATION PENDING. CONCOMITANT DEVICE ADDED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y THE SUTURE POPPED OFF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669245 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6F2931X

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR