BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURACLIP HEMOCLIP 16MM

    MDR report key: 8530295 · Received April 19, 2019

    Report

    Report Number
    3012396437-2019-00003
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    March 14, 2019
    Report Date
    May 16, 2019
    Manufacturer
    TRANSMED (CHINA) CO., LTD.
    Product Code
    PKL
    PMA / PMN Number
    K161463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CLIP WAS DEPLOYED PROPERLY THEN OPENED UP AND FELL OFF MUCOSA POST DEPLOYMENT. AND THE HOSPITAL DID NOT KEEP THE DEFECTIVE PRODUCTS AND COULD NOT PROVIDE MORE DETAILS ON CLINICAL USE (INCLUDING VIDEO AND PICTURES OF THE DEFECTIVE PRODUCTS). BASED ON THIS INFORMATION, WE ARE UNABLE TO EFFECTIVELY EVALUATE AND ANALYZE THE DEFECTIVE PRODUCTS. THEREFORE, WE CAN ONLY INVESTIGATE AND ANALYZE THE CLIPS OF RESERVED SAMPLES IN THE SAME BATCH, THE INTERNAL PRODUCTION RECORDS OF THE BATCHES OF CLIPS, AND THE HISTORY OF CUSTOMER USE: 1. ACCORDING TO THE CUSTOMER COMPLAINT DESCRIPTION, THE CLIP FELL OFF PROPERLY FROM THE TISSUE INCORRECTLY. WE FOCUS ON THE APPEARANCE OF THE CLIPS, THE OPEN WIDTH AND THE CLAMPING FORCE THAT MAY CAUSE THIS ISSUE. THE CUSTOMER DID NOT PROVIDE DEFECTIVE PRODUCTS. THEREFORE, WE CARRIED OUT RELEVANT INSPECTION AND TESTS ON THE CLIPS OF THE TWO RESERVED SAMPLES WITH THE SAME LOT NUMBER M181004231 AS THE CUSTOMER COMPLAINT. WE INSPECTED AND TESTED THE APPEARANCE, OPEN WIDTH AND CLAMPING FORCE OF THE RESERVED SAMPLES, AND FOUND THAT THEY ALL MET THE SPECIFICATION. WE ANALYZED THE PRODUCTS WITHOUT ABNORMALITIES AND THE CLIPS WERE QUALIFIED. 2. THE PRODUCT LOT NUMBER OF THE CUSTOMER FEEDBACK IS M181004231. AFTER INVESTIGATING THE CLIP AND THE CLAMP SEAT, WE CONFIRMED THAT THE DESIGN AND PRODUCTION PROCESS OF THE LOT OF CLIPS HAVE NOT CHANGED, AND THE MATERIAL AND PRODUCTION PROCESS OF THE RAW MATERIALS HAVE NOT BEEN CHANGED. 3. CHECK THE DHR OF THIS LOT, NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS, AND THE IN-PROCESS INSPECTION AND THE FINISHED INSPECTION WERE QUALIFIED. IN ADDITION, WE DID NOT RECEIVE SIMILAR COMPLAINTS OF THIS LOT FROM THE MARKET. CONCLUSION: SINCE THE CUSTOMER CANNOT PROVIDE COMPLAINT SAMPLES, VIDEOS AND PICTURES, WE CAN ONLY ANALYZE AND TEST THE RESERVED SAMPLES OF THE SAME BATCH OF CLIPS. AFTER ANALYSIS, WE CONFIRM THAT THE RESERVED SAMPLES ARE QUALIFIED. IN ADDITION, WE DID NOT RECEIVE OTHER SIMILAR CUSTOMER COMPLAINT. THE REAL CAUSE FOR THE FAILURE OF THE CLIPS CANNOT BE ANALYZED AND THE ROOT CAUSE CANNOT BE FOUND. REGARDING SUCH COMPLAINTS, WE WILL CONTINUE TO PAY ATTENTION TO THIS SITUATION. WE APOLOGIZE FOR THE INCONVENIENCE CAUSED TO DOCTORS AND PATIENTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE (B)(4), DURACLIP HEMOCLIP, 235CM 16MM, DEVICE WAS USED DURING A POLYPECTOMY ON (B)(6) 2019. IT IS REPORTED THAT THE CLIP WAS DEPLOYED PROPERLY, THEN OPENED AND FELL OFF THE MUCOSA POST DEPLOYMENT. THIS EVENT DID NOT CAUSE A DELAY OR CANCELLATION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DURACLIP TO CONTROL THE BLEEDING. THERE HAS BEEN NO INDICATION OF PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE USER HAS STATED THAT THERE ARE NO DEVICES BEING RETURNED FOR EVALUATION. HOWEVER, THE INCIDENT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE INCIDENT INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DC0235W, DURACLIP HEMOCLIP, 235CM 16MM, DEVICE WAS USED DURING A POLYPECTOMY ON (B)(6) 2019. IT IS REPORTED THAT THE CLIP WAS DEPLOYED PROPERLY, THEN OPENED AND FELL OFF THE MUCOSA POST DEPLOYMENT. THIS EVENT DID NOT CAUSE A DELAY OR CANCELLATION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DURACLLIP TO CONTROL THE BLEEDING. THERE HAS BEEN NO INDICATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324705 DURACLIP HEMOCLIP 16MM HEMOCLIP PKL TRANSMED (CHINA) CO., LTD. M181004231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other