BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 7470349 · Received April 27, 2018

    Report

    Report Number
    9612501-2018-00880
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    January 9, 2018
    Report Date
    June 6, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER E1999001. BRAND NAME: ENDO CLIP, ENDO CLIP II, ENDO CLIP III, PREMIUM SURGICLIP, PREMIUM SURGICLIP II, PREMIUM SURGICLIP III. MANUFACTURER NAME, CITY AND STATE: (B)(4). DEVICE IDENTIFICATION: (B)(4). 107 DEVICES EVALUATED, 160 DEVICES NOT EVALUATED (B)(4). PATIENT CODES: 1946, 2104, 2597, 2645 DEVICE CODES: 1104, 1184, 1212, 1384, 1584, 2522, 2532, 2578, 2610, 2921, 2936, 2796, 2983, 2984, 3024 RESULT CODE: 213, 3221, 3233, 3243, 3249 CONCLUSION CODE: 11, 67, 71, 92 H10. OF THE 267 EVENTS BEING REPORTED, 59 EVENTS WERE DETERMINED TO BE THE RESULT OF MISAPPLICATION BY THE USER, 46 EVENTS HAD NO DEVICE FAILURE, 2 EVENTS HAD ROOT CAUSES WHICH COULD NOT BE RELIABLY DETERMINED, 31 EVENTS ARE PENDING INVESTIGATION, 129 EVENTS HAD NO DEVICE RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES. NO VISUAL ABNORMALITIES WERE DETECTED. DURING FUNCTIONAL TESTING, THE DEVICES FIRED PROPERLY, BUT DID NOT HAVE TACTILE FEEDBACK WHILE FIRING. THE INSTRUMENTS WERE DISASSEMBLED AND THE LATCH COMPONENT WAS FOUND TO BE BROKEN. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL 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.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 267 MALFUNCTION EVENTS REPORTED BETWEEN JANUARY 1, 2018 TO MARCH 31, 2018. 5 EVENTS ASSOCIATED WITH UNDESIRED DAMAGE OR BREAKAGE OF THOSE MATERIALS USED IN DEVICE CONSTRUCTION. 2 EVENTS ASSOCIATED WITH THE UNINTENTIONAL SEPARATION OF THE DEVICE AND/OR ITS COMPONENTS FROM SOMETHING TO WHICH IT IS CONNECTED OR ATTACHED. 2 EVENTS ASSOCIATED WITH DEVICE FAILURE AND MALFUNCTION WHEN DEVICE DOES NOT DISPLAY ADEQUATE RESULTS OR HAVE PROPER DISPLAY. 1 EVENT ASSOCIATED WITH THE DEVICE AND/OR DEVICE ACCESSORIES CAUGHT WITHIN PATIENT VASCULATURE, TISSUE, OR OTHER DEVICES OR DEVICE COMPONENTS. 36 EVENTS ASSOCIATED WITH ANY DEVIATIONS FROM DEVICE DOCUMENTED PERFORMANCE SPECIFICATIONS RELATING TO MECHANICAL DEFECTS, INCLUDING MOVING PARTS OR SUBASSEMBLIES, ETC. 14 EVENTS ASSOCIATED WITH A SLIPPAGE OF DEVICE OR DEVICE COMPONENT 2 EVENTS ASSOCIATED WITH A CIRCUIT, EQUIPMENT, OR SYSTEM WHEREBY ITS FUNCTIONS FAIL TO BE PROPERLY SYNCHRONIZED OR ITS RELATIVE POSITIONS PROPERLY ORIENTED. 2 EVENTS ASSOCIATED WITH FAILURE OF DEVICE TO DISCHARGE ITS LOAD (E.G. SURGICAL STAPLER FAILED TO PARTIALLY OR COMPLETELY DEPLOY ITS STAPLES) 3 EVENTS ASSOCIATED WITH PHYSICAL RESISTANCE. 2 EVENTS ASSOCIATED WITH A THERAPY OR ALGORITHM NOT BEING DELIVERED OR EXECUTED AT THE EXPECTED TIME. 10 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. 2 EVENTS ASSOCIATED WITH A FAIL-SAFE MECHANISM ISSUE. 8 EVENTS ASSOCIATED WITH AN UNDESIRED MATERIAL CHANGE IN SHAPE OR PROPERTY CAUSED BY EXTERNAL FORCES. 1 EVENT ASSOCIATED WITH A PROBLEM THAT PREVENTS OR RESTRICTS THE MOTION OF THE DEVICE OR ITS COMPONENTS. 176 EVENTS ASSOCIATED WITH DEVICE MECHANICAL FUNCTIONING OF MACHINERY, MOVING PARTS OR TOOLS OF THE DEVICE BEING CHANGED OR MODIFIED. 1 EVENT ASSOCIATED WITH COMPRISING MATERIAL(S) BEING PULLED APART OR INTO PIECES BY FORCE, WRENCHING, OR LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310788 CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1