BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6171307 · Received December 13, 2016

    Report

    Report Number
    9612501-2016-01066
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 17, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    UDI-DI
    10884521100008
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKETING VIGILANCE (PMV) RECEIVED THREE SUTURING DEVICES OPENED BY THE ACCOUNT WITH THE APPROPRIATE DISPLAY BOX AND BLISTER PACKAGING IN AN UNDAMAGED CONDITION. 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. NO NEEDLE WAS RETURNED WITH THE INSTRUMENT. THE JAW GAP WAS MEASURED FOR ALL THREE INSTRUMENTS AND EACH ONE MET SPECIFICATION. WITNESS MARKS ON THE BEVEL WALL WERE OBSERVED FOR ALL THREE INSTRUMENTS. NO SHEERING ON THE TOGGLE SWITCHES WAS OBSERVED FOR EITHER INSTRUMENT. THE INSTRUMENT WAS 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. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT MET QUALITY RELEASE SPECIFICATIONS. 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 MOST PROBABLE ROOT CAUSE IS IMPROPER ORIENTATION OF THE NEEDLE IN THE RELOAD. BASED ON THE PRODUCT ANALYSIS, THE FAILURE WAS NOT CONFIRMED TO BE ATTRIBUTED TO THE REPORTED EVENT. 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). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PARAESOPHAGEAL HIATUS HERNIA REPAIR, THE SUTURE CAME OFF DEVICE. SUTURE WOULD NOT LOAD FOR 2ND AND 3RD DEVICE. GENDER, AGE AND WEIGHT ARE NOT AVAILABLE. NO PATIENT INJURY OR ILL-EFFECTS. NO MEDICAL INTERVENTION REQUIRED. PATIENT CURRENT STATUS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823100 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6E0566X 10884521100008

    Patients

    Seq Age Sex Outcome Treatment
    1