BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURACLIP HEMOCLIP 16MM

    MDR report key: 8402539 · Received March 7, 2019

    Report

    Report Number
    3012396437-2019-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    January 24, 2019
    Report Date
    March 7, 2019
    Manufacturer
    TRANSMED (CHINA) CO., LTD.
    Product Code
    PKL
    PMA / PMN Number
    K161463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THE CUSTOMER COMPLAINT, WE IMMEDIATELY COMMUNICATED WITH THE CUSTOMER ABOUT THE CLINICAL USE AND PATIENT INFORMATION, AS FOLLOWS: THE DOCTOR SAID THAT THE DEFECTIVE PRODUCTS WERE NOT SAVED. THEY ALSO COULD NOT PROVIDE RELEVANT VIDEOS OR PICTURES OF THE DEFECTIVE PRODUCTS. THE HOSPITAL IS UNABLE TO PROVIDE DEFECTIVE PRODUCTS OR MORE CLINICAL USE DETAILS (INCLUDING VIDEOS AND PICTURES OF DEFECTIVE PRODUCTS). BASED ON THIS INFORMATION, WE CANNOT EFFECTIVELY EVALUATE AND ANALYZE THE DEFECTIVE SAMPLES. AFTER COMMUNICATING WITH THE CUSTOMER, THE FACILITY DISCARDED THE DEVICE, THE CUSTOMER FAILED TO PROVIDE THE LOT NUMBER OF DEFECTIVE PRODUCTS. THEREFORE, WE CANNOT CHECK THE PRODUCTS PRODUCED IN THE SAME LOT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIPS APPEARED ABNORMALLY FALLING OFF AFTER THE TISSUES WERE GRIPPED. WE BELIEVE THAT THE REASON FOR THE ABNORMAL FALLING OFF AFTER THE CLIPS CLAMPED THE TISSUES MAY BE: CLIPS DEFORMATION, CLAMPING FORCE IS NOT ENOUGH. FOR THESE TWO POSSIBLE CAUSES, WE CONDUCTED INVESTIGATION AS BELOW: DURING THE PRODUCTION PROCESS, WE WILL PERFORM A 100% INSPECTION OF THE APPEARANCE OF THE CLIPS, AND THE CLAMPING FORCE WILL ALSO BE TESTED DURING THE PRODUCTION PROCESS. SINCE THE CUSTOMER COULD NOT PROVIDE THE CORRESPONDING LOT NUMBER, WE INSPECT THE PRODUCT OF THE SAME SPECIFICATION AND THE PERFORMANCES OF THE PRODUCTS ALL MEET THE REQUIREMENTS. CONCLUSION: BECAUSE THE FACILITY DISCARDED THE DEVICE, THE DEFECTIVE PRODUCTS AND LOT NUMBER WERE NOT AVAILABLE. THE CUSTOMER ALSO COULD NOT PROVIDE THE RELEVANT VIDEOS OR PHOTOS. IN ADDITION, WE DIDN'T RECEIVE A SIMILAR CUSTOMER COMPLAINT. WE CAN'T ANALYZE THIS ISSUE AND THE ROOT CAUSE CANNOT BE FOUND. WE WILL CONTINUE TO PAY ATTENTION TO THIS ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, WE RECEIVED A COMPLAINT FROM CUSTOMER ABOUT DURACLIP. IT WAS REPORTED THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) THE DOCTOR PLACED 5 CLIPS ON THE ANTRAL BULB DEFECT USING THE DCO235W, 16MM DURACLIP APPLIER. THERE WERE NO REPORTED ISSUES WITH THE INITIAL SURGERY, HOWEVER, THE PATIENT RETURNED A FEW DAYS LATER WITH BLEEDING BECAUSE A FEW OF THE CLIPS FELL OFF. THE PATIENT WAS HOSPITALIZED. FURTHER ATTEMPTS WERE MADE TO FIND OUT WHAT INTERVENTION WERE DONE; HOWEVER, NO OTHER INFORMATION WAS RECEIVED OTHER THAN THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195730 DURACLIP HEMOCLIP 16MM HEMOCLIP PKL TRANSMED (CHINA) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other