BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* SURGIDAC*2/0 48 GRN DLU TU

    MDR report key: 6045690 · Received October 20, 2016

    Report

    Report Number
    9612501-2016-00816
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 23, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE ENDO STITCH* SURGIDAC* 2/0 48 GRN DLU SU 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 DEVICES. TWO OF THE ENDO STITCH* SURGIDAC* 2/0 48 GRN DLU SU RECEIVED HAD NO NEEDLES REMAINING. TWO NEEDLES WERE RECEIVED ON THE LAST ENDO STITCH* SURGIDAC* 2/0 48 GRN DLU SU. THE VISUAL INSPECTION OF THE ENDO STITCH* SURGIDAC* 2/0 48 GRN DLU SU NEEDLES NOTED NO WITNESS MARKS. THE NEEDLES WERE LOADED ONTO THE PMV ENDO STITCH* DEVICE. THE NEEDLES WERE FOUND TO FUNCTION PROPERLY WHEN APPLIED THROUGH LAYERS OF TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLES IN ALL DIRECTIONS AND FROM BOTH SIDES OF THE JAW TO SIMULATE CLINICAL CONDITIONS. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLES. 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. 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).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE TECH WENT TO LOAD THE SUTURE ONTO THE DEVICE, THE SUTURE ITSELF DID NOT LINE UP PROPERLY WITH THE APPLIER AND COULD NOT BE LOADED. THE TECH AND SURGEON BOTH COULD NOT LOAD IT PROPERLY. THE EVENT WAS INVESTIGATED WITH THE OPERATING ROOM NURSE AND THE SURGICAL TECH. IT WAS DETERMINED BY THE USER FACILITY THAT THE COMPONENT ITSELF WAS FAULTY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THEY OPENED A DIFFERENT SUTURE TO COMPLETE THE PROCESS WITHOUT FURTHER ISSUE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE RELOAD DID NOT LINE PROPERLY WHEN LOADED INTO THE DEVICE (6 OUT OF 7 TIMES). TWO SEPARATE LOTS ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696651 ENDO STITCH* SURGIDAC*2/0 48 GRN DLU TU ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 170044 J6A1971X

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR SURGIDAC SULU.