BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK L CLIPS 6/CART 84/BOX

    MDR report key: 4180344 · Received October 15, 2014

    Report

    Report Number
    3003898360-2014-00827
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    TELEFLEX
    Product Code
    MCH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT RETURNED. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: DURING A LAPAROSCOPIC RIGHT SURRENALECTOMY (ADRENALECTOMY) SURGERY, THE PRINCIPAL SURRENAL VEIN WAS LOCATED TO BE SECTION BETWEEN 2 CLIPS. THE CLIPS IN THIS CARTRIDGE DID NOT WORK, THEY DID NOT CLOSE. THE PT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654015 WECK HEMOLOK L CLIPS 6/CART 84/BOX LIGATING CLIPS MCH TELEFLEX 01B1400269

    Patients

    Seq Age Sex Outcome Treatment
    1