BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP II

    MDR report key: 7718898 · Received July 25, 2018

    Report

    Report Number
    9612501-2018-01355
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Report Date
    October 4, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (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: COVIDIEN LP LLC, (B)(4). BRAND NAME: ENDO CLIP, ENDO CLIP II, ENDO CLIP III, PREMIUM SURGICLIP, PREMIUM SURGICLIP II, PREMIUM SURGICLIP III. MANUFACTURER NAME, CITY AND STATE: COVIDIEN LP LLC (B)(4). DEVICE IDENTIFICATION: 176615, 176619, 176620, 176625, 176657, 176630, 134031, 134044, 134046, 134048, 134051, 134053, 133650. 136 DEVICES EVALUATED, 5 DEVICES NOT EVALUATED. PATIENT CODES: 2104, 2645, 3191, 2692 DEVICE CODES: 3024, 1584, 2578, 2532, 2984, 1384, 1069, 2936, 2921, 2983, 1184, 2522, 1104, 2976 RESULT CODE: 110, 170, 213, 3221, 3243, 706 CONCLUSION CODE: 11, 23, 61, 67, 71, 92. OF THE 141 EVENTS BEING REPORTED, 60 EVENTS WERE DETERMINED TO BE THE RESULT OF MISAPPLICATION BY THE USER, 52 EVENTS HAD NO DEVICE FAILURE, 24 EVENTS WERE DETERMINED TO THE RESULT OF A ASSEMBLY OR COMPONENT ERROR, AND 5 EVENTS HAD NO DEVICE RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER E1999001. UPON THE RESULTS OF FURTHER INVESTIGATION, AN ADDITIONAL 4 REPORTS WILL BE REPORTED UNDER THIS EXEMPTION NUMBER. 4 DEVICES EVALUATED. PATIENT CODES: 2692 DEVICE CODES: 2921, 1384, 2984 RESULT CODES: 3243, 213 CONCLUSION CODES: 61, 71. OF THE 4 EVENTS BEING REPORTED, 3 EVENTS WERE DETERMINED TO BE THE RESULT OF MISAPPLICATION BY THE USER AND 1 EVENT HAD NO DEVICE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 141 MALFUNCTION EVENTS REPORTED BETWEEN (B)(6) 2018. ONE EVENT ASSOCIATED WITH COMPRISING MATERIAL(S) BEING PULLED APART OR INTO PIECES BY FORCE, WRENCHING, OR LACERATION. SEVEN EVENTS ASSOCIATED WITH A SLIPPAGE OF DEVICE OR DEVICE COMPONENT. ONE EVENT ASSOCIATED WITH PHYSICAL RESISTANCE. ONE EVENT ASSOCIATED WITH FAILURE OF DEVICE TO DISCHARGE ITS LOAD. NINETY EIGHT EVENTS ASSOCIATED WITH DEVICE MECHANICAL FUNCTIONING OF MACHINERY, MOVING PARTS OR TOOLS OF THE DEVICE BEING CHANGED OR MODIFIED. THIRTEEN EVENTS ASSOCIATED WITH ANY DEVIATIONS FROM DEVICE DOCUMENTED PERFORMANCE SPECIFICATIONS RELATING TO MECHANICAL DEFECTS, INCLUDING MOVING PARTS OR SUBASSEMBLIES, ETC. TWO EVENTS ASSOCIATED WITH UNDESIRED DAMAGE OR BREAKAGE OF THOSE MATERIALS USED IN DEVICE CONSTRUCTION. TWO EVENTS ASSOCIATED WITH A FAIL-SAFE MECHANISM ISSUE. SEVEN 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. ONE EVENT ASSOCIATED WITH A PROBLEM THAT PREVENTS OR RESTRICTS THE MOTION OF THE DEVICE OR ITS COMPONENTS. TWO EVENTS ASSOCIATED WITH DEVICE FAILURE AND MALFUNCTION WHEN DEVICE DOES NOT DISPLAY ADEQUATE RESULTS OR HAVE PROPER DISPLAY. TWO EVENTS ASSOCIATED WITH A CIRCUIT, EQUIPMENT, OR SYSTEM WHEREBY ITS FUNCTIONS FAIL TO BE PROPERLY SYNCHRONIZED OR ITS RELATIVE POSITIONS PROPERLY ORIENTED. ONE EVENT ASSOCIATED WITH THE UNINTENTIONAL SEPARATION OF THE DEVICE AND/OR ITS COMPONENTS FROM SOMETHING TO WHICH IT IS CONNECTED OR ATTACHED. THREE EVENTS ASSOCIATED WITH AN UNDESIRED MATERIAL CHANGE IN SHAPE OR PROPERTY CAUSED BY EXTERNAL FORCES.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 4 ADDITIONAL MALFUNCTION EVENTS REPORTED BETWEEN APRIL 1, 2018 AND JUNE 30, 2018 2 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 ANY DEVIATIONS FROM DEVICE DOCUMENTED PERFORMANCE SPECIFICATIONS RELATING TO MECHANICAL DEFECTS, INCLUDING MOVING PARTS OR SUBASSEMBLIES, ETC. 1 EVENT 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
    563314 ENDO CLIP II CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176657

    Patients

    Seq Age Sex Outcome Treatment
    1