BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURACLIP HEMOCLIP 16MM

    MDR report key: 8406944 · Received March 11, 2019

    Report

    Report Number
    3012396437-2019-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    January 24, 2019
    Report Date
    April 3, 2019
    Manufacturer
    TRANSMED (CHINA) CO., LTD.
    Product Code
    PKL
    PMA / PMN Number
    K161463
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ACTIVELY COMMUNICATING WITH THE CUSTOMER, THE CUSTOMER FAILED TO PROVIDE SAMPLES, AND DID NOT SEND US AN ABNORMAL PICTURE TO CONFIRM. LOOKING BACK AT THE PHENOMENON OF CUSTOMER COMPLAINTS IN RECENT YEARS, COMBINED WITH THE CUSTOMER COMPLAINTS, AFTER THE PRODUCT IS RELEASED, THE PULL HOOK IS BROKEN AND THE METAL IS CUT OFF. WE ANALYZED THAT WHEN THE PULL HOOK OPENING IS ON THE SIDE, WHEN THE FORCE IS APPLIED, THE PULL HOOK STARTS TO MOVE DOWNWARD. THE TOP OF THE PULL HOOK IS STRESSED, IT IS DETACHED FROM THE PIN ROLL, AND THE OPENING IS PULLED FROM THE SIDE TO THE TOP. IT SEPARATED FROM THE CLIP ASSEMBLY. DURING THE CLIP RELEASE PROCESS, THE HEAD OF PULL HOOK HAS A LARGE DEFORMATION, DURING THE DOWNWARD MOVEMENT OF THE PULL HOOK, THERE IS A RISK OF METAL CHIPS FALLING AFTER THE TOP IS STRESSED. TO IMPROVE THE PRODUCT EXPERIENCE, WE WILL TRY TO CHANGE THE SLOTTING FROM THE SIDE TO THE MIDDLE. WHEN THE PULL HOOK IS STRESSED, IT STARTS TO MOVE DOWNWARDS. WHEN THE TOP IS STRESSED, THE AMOUNT OF DEFORMATION IS DISPERSED. AS THE FORCE INCREASES, THE PULL HOOK CAN DISENGAGE FROM THE PIN ROLL BEFORE REACHING THE DEFORMATION LIMIT. AFTER THE NEW PULL HOOK IS STRESSED, ONLY THE OPENING DISTANCE OF THE FRONT END CIRCLE CHANGES, AND THERE IS NO BREAK POINT AROUND THE OPEN CIRCLE, SO THE PULL HOOK CAN BE PREVENTED FROM BEING BROKEN INTO THE HUMAN BODY BY FORCE. THE PULL HOOK OF THE PRODUCT BREAKS AND THE METAL CHIPS FALL, WHICH IS ONLY AFTER THE CLIP IS RELEASED NORMALLY. IT DOES NOT AFFECT THE SURGICAL PROCEDURE OF THE MEDICAL STAFF. THE CLIP ASSEMBLY ITSELF WILL BE IMPLANTED IN THE BODY FOR A PERIOD OF TIME AND WILL FALL OFF AS THE WOUND HEALS. AFTER SHEDDING, IT WILL EXCRETE WITH THE DIGESTIVE TRACT. COMPARED TO THE CLIP ITSELF, THE DROPPED PARTS ARE MUCH SMALLER THAN THE CLIP ASSEMBLY. WE ALSO INVITED SEVERAL CHIEF PHYSICIANS IN THE DEPARTMENT OF GASTROENTEROLOGY TO CONDUCT A SEVERITY ASSESSMENT BY EVALUATING CLINICAL PHOTOGRAPHS AND PHYSICAL OBJECTS TO THE DIGESTIVE DOCTOR. THE ASSESSMENT BELIEVES THAT THE SIZE OF THE FOREIGN BODY IS VERY SMALL AND CAN BE COMPLETELY DISCHARGED THROUGH THE DIGESTIVE TRACT. IT WILL NOT CAUSE DAMAGE TO THE DIGESTIVE TRACT, AND IT CAN BE EXCRETED WITH THE DIGESTIVE TRACT WITHOUT CAUSING HARM TO THE PATIENT. WE WILL CONTINUE TO PAY ATTENTION TO THIS ISSUE TO ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A POEMS PROCEDURE ON (B)(6), 2019 THE DC0235W, DURACLIP BROKE AND A FRAGMENT OF THE CLIP WAS RETRIEVED FROM THE PATIENT. THE FRAGMENT WAS RETRIEVED USING A GRASPER. THERE WAS A 10-MINUTE DELAY OF SURGERY. THE SURGICAL TEAM WAS VERY FAMILIAR WITH USING THE PRODUCT. THE DURACLIP HAD DEPLOYED 2 CLIPS SUCCESSFULLY PRIOR TO THIS CLIP BREAKING. THERE WAS NO PATIENT INJURY OR IMPACT REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED, HOWEVER THE COMPLAINT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A POEMS PROCEDURE ON (B)(6) 2019 THE DC0235W, DURACLIP BROKE AND A FRAGMENT OF THE CLIP WAS RETRIEVED FROM THE PATIENT. THE FRAGMENT WAS RETRIEVED USING A GRASPER. THERE WAS A 10-MINUTE DELAY OF SURGERY. THE SURGICAL TEAM WAS VERY FAMILIAR WITH USING THE PRODUCT. THE DURACLIP HAD DEPLOYED 2 CLIPS SUCCESSFULLY PRIOR TO THIS CLIP BREAKING. THERE WAS NO PATIENT INJURY OR IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200411 DURACLIP HEMOCLIP 16MM HEMOCLIP PKL TRANSMED (CHINA) CO., LTD. M181107231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other