BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURACLIP HEMOCLIP 16MM

    MDR report key: 8469601 · Received April 1, 2019

    Report

    Report Number
    3007216334-2019-00096
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    January 24, 2019
    Report Date
    April 1, 2019
    Manufacturer
    TRANSMED (CHINA) CO LTD
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: THIS COMPLAINT WAS PREVIOUSLY FILED UNDER 1320894-2019-00034 AS THE MANUFACTURER. IT HAS SINCE BEEN DETERMINED THAT TRANSMED IS THE RESPONSIBLE PARTY, WE ARE THE IMPORTER. (B)(4). DISTRIBUTOR NARRATIVE; THE MANUFACTURER, TRANSMED (B)(4) CO. LTD, IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH (B)(4) CORPORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT: 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 THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261692 DURACLIP HEMOCLIP 16MM HEMOCLIP PKL TRANSMED (CHINA) CO LTD M181107231

    Patients

    Seq Age Sex Outcome Treatment
    1