BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6103136 · Received November 15, 2016

    Report

    Report Number
    9612501-2016-00906
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HANDLE AND RELOAD WERE RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATED BY MFR?, EVALUATION CODES. 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 LOADED ON THE DEVICE. THE VISUAL INSPECTION OF THE DEVICE HAD NO WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL SURROUNDING THE NEEDLE RECEPTACLE, INDICATING PROPER ALIGNMENT OF THE JAWS WHEN TOGGLING THE NEEDLE. THE VISUAL INSPECTION OF THE NEEDLE NOTED WITNESS MARKS ON EACH OF THE CONES. 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. AFTER FURTHER VISUAL INSPECTION, SOME PLASTIC SHEARING WAS NOTED ON THE TOGGLE SWITCH. THE TOGGLE SHOULD ONLY BE ACTIVATED WHEN THE HANDLES AND JAWS ARE IN THE CLOSED POSITION. FAILURE TO DO SO MAY DAMAGE THE DEVICE. THIS OCCURS WHEN PRESSURE IS APPLIED ON THE TOGGLE LEVER PRIOR TO CLOSING THE HANDLES AND PREMATURELY ATTEMPTING TO TOGGLE, RESULTING IN THE SHAVING CONDITIONS NOTED. 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. A REVIEW OF THE CURRENT HISTORICAL COMPLAINT DATA REVEALS THAT THIS FAILURE MODE AND/ COMPLAINT MODE (NEEDLE DISENGAGED) WAS IDENTIFIED AS A TREND ON (FEBRUARY 2016). A REVIEW OF THE CURRENT HISTORICAL COMPLAINT DATA REVEALS THAT THIS FAILURE MODE AND/ COMPLAINT MODE (COMPONENT DISENGAGED INTO CAVITY (RETRIEVED)) WAS IDENTIFIED AS A TREND ON (DECEMBER 2016). 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SURGEON WAS PERFORMING A PROCEDURE WITH THE DEVICE. THERE WAS DIFFICULTY LOADING THE SUTURE. AT THE VERY END, THE V-LOCK NEEDLE STOPPED TRANSFERRING FROM ONE SIDE TO THE OTHER. THE NEEDLE WOULD NOT SETTLE BACK INTO A NEUTRAL POSITION. THE NEEDLE DISENGAGED FROM THE DEVICE INTO THE PATIENT CAVITY BUT WAS RETRIEVED WITHOUT ISSUE. THE SURGEON COULD NOT COMPLETE CLOSING THE CUFF WITH THE DEVICE AND WAS FORCED TO OPEN ANOTHER DEVICE AND SUTURE TO FINISH THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754285 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016 J6H1745X

    Patients

    Seq Age Sex Outcome Treatment
    1