BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6611311 · Received June 5, 2017

    Report

    Report Number
    9612501-2017-05578
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    April 17, 2017
    Report Date
    September 6, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    UDI-DI
    20884521100005
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: OCW; COMMON DEVICE NAME: ENDOSCOPIC TISSUE APPROXIMATION DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:POST MARKET VIGILANCE (PMV) RECEIVED ONE DEVICE OPENED BY THE ACCOUNT WITH THE APPROPRIATE PACKAGING IN AN UNDAMAGED CONDITION. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED: WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL WERE OBSERVED. NO SHEARING OF THE TOGGLE SWITCHES WAS OBSERVED FOR THE DEVICES UNDER MICROSCOPIC INSPECTION. PMV PERFORMED FUNCTIONAL TESTING ON DEVICE. DEVICE 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. DEVICE WAS FOUND TO NOT FUNCTION PROPERLY AS NEEDLE DISENGAGED WHILE BEING TOGGLED IN MEDIA AND BEING TOGGLE OUTSIDE OF MEDIA. NO DIFFICULTY WAS EXPERIENCED IN LOADING AND UNLOADING THE NEEDLE IN THE TESTED DEVICE. DIFFICULTY WAS EXPERIENCED IN TOGGLING THE NEEDLE IN THE DEVICE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING BARIATRIC LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT WORK PROPERLY. THE THREAD FELL INTO PATIENT CAVITY. THE DEVICE WAS DIFFICULT TO TOGGLE AND LOAD. USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. NO INJURY TO PATIENT, PATIENT STATUS; ALIVE - NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393369 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 J6M1325X 20884521100005

    Patients

    Seq Age Sex Outcome Treatment
    1