BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 5742580 · Received June 22, 2016

    Report

    Report Number
    9612501-2016-00182
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 1, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL LOT NUMBER OF DEVICE USED IN THIS PROCEDURE IS UNKNOWN. REPORTEDLY, THE ACCOUNT HAD THE FOLLOWING LOTS J6B0810X AND J6C1613X IN STOCK AT THE TIME THE EVENT WAS REPORTED TO THE MANUFACTURER. MULTIPLE LOTS REPORTED: J6B0810X EXPIRATION DATE: 02/28/2021, J6C1613X EXPIRATION DATE 03/31/2021. DEVICE MANUFACTURE DATE: J6B0810X DEVICE MANUFACTURING DATE: 02/01/2016, J6C1613X DEVICE MANUFACTURING DATE: 03/01/2016.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKETING VIGILANCE CONCURRENTLY WITH ENGINEERING LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT WITH THE APPROPRIATE DISPLAY BOX IN AN UNDAMAGED CONDITION AND ONE RELOAD OPENED BY THE ACCOUNT. A VIDEO OF THE PROCEDURE WAS ALSO RECEIVED. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, PMV REVIEW OF COMPLAINT TRENDS AND AN EVALUATION OF THE RETURNED DEVICE. NO WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL SURROUNDING THE NEEDLE RECEPTACLE WERE NOTED FOR THE DEVICE, INDICATING PROPER ALIGNMENT OF THE JAWS WHEN TOGGLING THE NEEDLE. THE NEEDLE DEMONSTRATED GOUGE MARKS AT THE DISTAL END OF THE CONE INDICATING THAT THE HANDLES MAY NOT HAVE BEEN FULLY SQUEEZED DURING TOGGLING. ENGINEERING ANALYSIS OF THE VIDEO CONCLUDED THAT THE NEEDLE WAS EXPOSED TO POTENTIAL LOADING ISSUES AND THEN EXPOSED TO ABUSIVE CONDITIONS BY THE USER, SOME OF THE TISSUE MASS THE USER TRIED TO PASS THE NEEDLE THROUGH WAS EXCESSIVE. THE SUBJECT NEEDLE WAS LOADED ONTO THE SUBJECT INSTRUMENT. 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. THE NEEDLE WAS LOADED AND UNLOADED WITHOUT DIFFICULTY. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLE. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT MET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS . A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE.BASED ON THE VIDEO ANALYSIS, IMPROPER LOADING AND USE IN THICK TISSUE MAY HAVE CAUSED THE REPORTED CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A MINIMALLY INVASIVE ESOPHAGECTOMY, (MIE), A DEVICE WAS OPENED AND HAD DROPPED THE FIRST 7 INCH RELOAD THAT WAS LOADED. THIS WAS THE THIRD SUTURE APPLIER DEVICE USED DURING THE SURGERY. THE OPENED 7 INCH RELOADS WERE ISOLATED. FORTY-EIGHT INCH RELOADS WERE OPENED WITH NO ADDITIONAL ISSUES NOTED. SIX RELOADS WERE USED ON THE THORACIC PORTION OF THE MIE PROCEDURE WITH NO ISSUE. ALL NEEDLES WERE RECOVERED FROM THE ABDOMEN. NO ADVERSE EVENTS HAVE BEEN REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396972 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1