BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURACLIP

    MDR report key: 20742121 · Received November 21, 2024

    Report

    Report Number
    3004837686-2024-00012
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MICRO-TECH(NANJING) CO.,LTD.
    Product Code
    PKL
    PMA / PMN Number
    K161463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER MICRO-TECH RECEIVED THIS INCIDENT. WE REVIEWED THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. WE ARE TRYING TO GET MORE INFORMATION FOR INVESTIGATION. WE WILL FILL A FOLLOW-UP REPORT WHEN THIS INCIDENT INVESTIGATION IS DONE.

    Additional Manufacturer Narrative · 0

    1. DESCRIPTION OF INCIDENT: DURA CLIP DID NOT DEPLOY, AND THE END OF IT CAME OFF AFTER THE DEVICE WAS REMOVED FROM THE SCOPE. 2. EXTERNAL INVESTIGATION: ON (B)(6) 2024, MICRO-TECH HAS COMMUNICATED WITH CUSTOMER TO DETERMINE IF THERE ARE ANY OTHER CLINICAL INFORMATION. AS OF DECEMBER 10, 2024, NO RESPONSE HAS BEEN RECEIVED. MEANWHILE, MICRO-TECH CONDUCT AN INTERNAL INVESTIGATION AND ANALYSIS. 3. INTERNAL INVESTIGATION: BASED ON THE CUSTOMER'S DESCRIPTION AND HISTORICAL CUSTOMER COMPLAINTS, WE CONFIRM THAT THERE IS A PHENOMENON OF EXTERNAL TUBE SEPARATION BUT INTERNAL CONNECTION IN THE CLIP. IN RESPONSE TO THIS PHENOMENON, WE CONDUCT THE FOLLOWING ANALYSIS BASED ON HISTORY: 3.1 STRUCTURAL DESIGN: THE PRODUCT CONSISTS OF CLIP COMPONENT, SPRING TUBE, AND HANDLE. ANALYSIS: THE WORKING PRINCIPLE OF THE CLIP IS AS FOLLOWS: THE EFFECTIVE LENGTH OF THE CLIP ENTERS THE ENDOSCOPE CAVITY, AND THE CLIP COMPONENT COMES INTO CONTACT WITH THE MUCOSAL TISSUE. THE SPRING TUBE AND THE CLIP COMPONENT ARE MECHANICALLY CONNECTED, AND THE SLIDE BLOCK TRANSMITS FORCE TO THE CLIP TO ACHIEVE OPENING AND CLOSING. THE REPEATED OPENING AND CLOSING PERFORMANCE IS ACHIEVED THROUGH THE SLIDE GROOVE OF THE CLIP. BY UTILIZING THE SELF-LOCKING STRUCTURE OF THE CLIP ITSELF, THE CLIP IS CLOSED AND SEPARATED FROM THE OUTER TUBE, THEREBY COMPLETING THE RELEASE OF THE CLIP. 3.2 PRODUCTION PROCESS: WE HAVE INVESTIGATED ALL PROCESSES RELATED TO THE CLIP COMPONENTS DURING THE PRODUCTION PROCESS AND EVALUATED THEM BASED ON THE FAILURE MODES IN PFMEA. THIS INCIDENT WAS CAUSED BY THE SEPARATION OF THE CLIP PEDESTAL FROM THE OUTER TUBE COMPONENT BUT STILL CONNECTED TO THE INNER CORE. IN PFMEA, WE NEED TO INSPECT THE CLIP HOOK FOR DEFORMATION, SHORTENING, AND OTHER PHENOMENA AFTER INSTALLING THE CLIP PEDESTAL TO ADDRESS THIS PROCESS RISK; ASSEMBLE QUALIFIED PRODUCTS FOR PROCESS INSPECTION, AND PROCESS INSPECTORS NEED TO INSPECT WHETHER THE GRIP HOOK OF THE PRODUCT IS STUCK IN THE CLIP PEDAL; BEFORE PACKAGING, THE PACKAGING PERSONNEL NEED TO CHECK THE REPEATED OPENING AND CLOSING PERFORMANCE OF THE PRODUCT, AND AFTER PASSING THE INSPECTION, PUT ON A PROTECTIVE COVER FOR PACKAGING. AT THE SAME TIME, BASED ON THE INVESTIGATION OF COMPLAINT INFORMATION, IT HAS BEEN CONFIRMED THAT THERE HAVE BEEN NO CHANGES IN THE DESIGN AND PRODUCTION PROCESS OF THIS BATCH OF CLIPS, AND NO CHANGES HAVE BEEN MADE TO THE RAW MATERIAL MATERIALS OR PRODUCTION PROCESS. THEREFORE, WE CONFIRM THAT ANY FAILURES THAT MAY OCCUR DURING THE PRODUCTION PROCESS HAVE BEEN IDENTIFIED AND CONTROLLED BEFORE LEAVING THE FACTORY, AND THE PRODUCTION PROCESS CAN PREVENT SUCH INCIDENTS FROM HAPPENING. 3.3 INSTRUCTIONS FOR USE: THE CLIP REACHES THE AFFECTED AREA THROUGH THE ENDOSCOPIC BIOPSY CHANNEL, GENTLY MOVES THE DISTAL SLIDE BLOCK, OPENS THE CLIP, CLOSES THE CLIP AT THE DESIRED LOCATION, AND MOVES THE SLIDER TO THE PROXIMAL END TO CLOSE THE CLIP. AFTER PASSING THE FIRST RESISTANCE POINT AND HEARING OR FEELING THE FIRST CLICK, DO NOT ATTEMPT TO OPEN THE CLIP. REOPENING THE CLIP MAY CAUSE IT TO SEPARATE FROM THE CATHETER, RESULTING IN TWISTING OR DAMAGE TO THE DEVICE. AFTER PASSING THROUGH THE FIRST RESISTANCE POINT, IF IT IS FOUND THAT THE CLIP IS SEPARATED FROM THE CATHETER AND THE INNER CORE IS STILL CONNECTED TO THE CLIP, SIMPLY CONTINUE TO PULL THE HANDLE BACK TO COMPLETE THE SUBSEQUENT RELEASE ACTION, AND THE CLIP CAN STILL BE RELEASED NORMALLY. (IT SHOULD BE NOTED THAT WHEN THE OUTER TUBE SEPARATES AND THE INNER CORE IS CONNECTED, WHEN PULLING THE CLIP TO CONTINUE RELEASING, IT IS NECESSARY TO AVOID INTERFERENCE BETWEEN THE CONNECTING TUBE OF THE INNER CORE AND THE OUTER TUBE, OTHERWISE THE FORCE CANNOT BE TRANSMITTED TO THE CLIP, WHICH MAY RESULT IN THE INABILITY TO RELEASE.) 3.4 OPERATING ENVIRONMENT: THIS DEVICE NEEDS TO BE USED IN CONJUNCTION WITH AN ENDOSCOPE. BEFORE INSERTING THE ENDOSCOPE, ENSURE THAT THE FIELD OF VIEW IS CLEAR. IF THE DISTAL END OF THE INSERTED PART OF THE INSTRUMENT CANNOT BE SEEN THROUGH THE ENDOSCOPIC FIELD OF VIEW, PLEASE DO NOT USE THE INSTRUMENT. WHEN INSERTING INSTRUMENTS INTO AN ENDOSCOPE, THE FIELD OF VIEW IS UNCLEAR, WHICH MAY CAUSE PATIENT DAMAGE SUCH AS PERFORATION, BLEEDING, OR MUCOSAL INJURY, AND MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENTS. ANALYSIS: THE SUPPORTING EQUIPMENT INVOLVED IN THE USE OF THE CLIP IS AN ENDOSCOPE. WHEN INSERTING THE CLIP INTO THE ENDOSCOPE, IT IS NECESSARY TO ENSURE THAT THE CLIP ENTERS IN A CLOSED STATE. AFTER COMPLAINING, WE ANALYZED THAT THE CLIP CAN SMOOTHLY PASS THROUGH THE ENDOSCOPE AND REACH THE DESIRED POSITION TO CLAMP THE TISSUE. AFTER CLAMPING THE TISSUE, THE SUBSEQUENT RELEASE ACTION WAS COMPLETED DUE TO THE FAILURE TO CONTINUE PULLING THE HANDLE. THEREFORE, WE CAN CONFIRM THAT THE USE ENVIRONMENT WILL NOT CAUSE SUCH INCIDENTS IN THE CLIP. 3.5 STORAGE AND TRANSPORTATION: WE HAVE CLEAR REQUIREMENTS FOR THE STORAGE AND TRANSPORTATION OF CLIP PRODUCTS: STORAGE: THE PRODUCT SHOULD BE STORED IN A CLEAN, WELL VENTILATED, AND NON CORROSIVE GAS ENVIRONMENT. TRANSPORTATION: THE PRODUCT SHOULD BE PROTECTED FROM HEAVY PRESSURE, DIRECT SUNLIGHT, AND RAIN DURING TRANSPORTATION, OR AS SPECIFIED IN THE PURCHASE CONTRACT. ANALYSIS: THE CLIP UNDERWENT DETAILED VALIDITY PERIOD VERIFICATION AND TRANSPORTATION CONFIRMATION DURING THE DESIGN AND DEVELOPMENT PHASE, CONFIRMING THAT THE CLIP IS SAFE AND EFFECTIVE WITHIN ITS VALIDITY PERIOD. CLIP ALSO CONDUCTED TRANSPORTATION CONFIRMATION, CONFIRMING THAT THE PACKAGING METHOD CAN MEET THE PROTECTION REQUIREMENTS OF THE PRODUCT, AND MORE DETAILED STORAGE AND TRANSPORTATION CONDITIONS ARE ALSO DESCRIBED IN THE INSTRUCTION MANUAL. THEREFORE, WE CONFIRM THAT THE STORAGE AND TRANSPORTATION METHOD WILL NOT CAUSE SUCH ADVERSE EFFECTS ON CLIPS, RESULTING IN SUCH INCIDENTS. SUMMARY: BASED ON HISTORICAL CUSTOMER COMPLAINTS ANALYSIS, THE POSSIBLE REASON IS THAT AFTER THE CLIP WAS FORCED TO CLOSE, IT WANTED TO BE PUSHED OPEN AGAIN, RESULTING IN THE SEPARATION OF THE OUTER TUBE AND THE CONNECTION OF THE INNER CORE. AT THIS POINT, IN ORDER TO COMPLETE THE FIRST SEPARATION POINT IN THE RELEASE ACTION AND THE CLOSING SELF-LOCKING ACTION, IF THE HANDLE IS PUSHED FORWARD FURTHER, THE CLIP CANNOT BE OPENED. WE SUGGEST THAT THE SAFE OPERATION AT THIS TIME IS TO CONTINUE PULLING THE HANDLE BACK TO COMPLETE THE SUBSEQUENT RELEASE ACTION, AND THE CLIP CAN STILL BE RELEASED NORMALLY.

    Description of Event or Problem · 0

    ON NOVEMBER 14, 2024. MICRO-TECH RECEIVED AN INCIDENT REGARDING DURACLIP FROM TRANSMED (CHINA) CO., LTD. IT WAS REPORTED THAT DURACLIP DID NOT DEPLOY, AND THE END OF IT CAME OFF AFTER THE DEVICE WAS REMOVED FROM THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430195 DURACLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL MICRO-TECH(NANJING) CO.,LTD. M220301592

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female