BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 7470365 · Received April 27, 2018

    Report

    Report Number
    9612501-2018-00882
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Report Date
    June 6, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GDO
    PMA / PMN Number
    K071406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. NO VISUAL ABNORMALITIES WERE DETECTED. DURING FUNCTIONAL TESTING, THE DEVICE FIRED PROPERLY, BUT DID NOT HAVE TACTILE FEEDBACK WHILE FIRING. THE INSTRUMENT WAS DISASSEMBLED AND THE LATCH COMPONENT WAS FOUND TO BE BROKEN. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY AND A PRODUCT ENHANCEMENT HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM RECURRING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER E1999001. 6 DEVICES EVALUATED, 4 DEVICES NOT EVALUATED. DEVICE CODES: 2984, 2921, 2976, 3273, 1212 RESULT CODES: 3243, 213, 3233 CONCLUSION CODES: 11, 61, 71. OF THE 10 EVENTS BEING REPORTED, 3 EVENTS WERE DETERMINED TO BE THE RESULT OF MISAPPLICATION BY THE USER, 3 EVENTS HAD NO DEVICE FAILURE, AND 4 EVENTS HAD NO DEVICE RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS REPORTED BETWEEN JANUARY 1, 2018 AND MARCH 31, 2018. 1 EVENT ASSOCIATED WITH THE UNINTENTIONAL SEPARATION OF THE DEVICE AND/OR ITS COMPONENTS FROM SOMETHING TO WHICH IT IS CONNECTED OR ATTACHED. 3 EVENTS ASSOCIATED WITH THE USE OF THE DEVICE IN TERMS OF USER EXPERIENCING DIFFICULTY OPENING AND CLOSING THE DEVICE, EVEN IF THE OPERATION IS BEING PERFORMED ACCORDING TO LABELED INSTRUCTIONS FOR USE. 1 EVENT ASSOCIATED WITH AN UNDESIRED MATERIAL CHANGE IN SHAPE OR PROPERTY CAUSED BY EXTERNAL FORCES. 5 EVENTS ASSOCIATED WITH DEVICE MECHANICAL FUNCTIONING OF MACHINERY, MOVING PARTS OR TOOLS OF THE DEVICE BEING CHANGED OR MODIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311076 ENDO CLIP III APPLIER, SURGICAL, CLIP GDO DAVIS & GECK CARIBE LTD 176630B

    Patients

    Seq Age Sex Outcome Treatment
    1