BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 4202379 · Received September 15, 2014

    Report

    Report Number
    3003898360-2014-00695
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 20, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER HOWEVER THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: IT WAS REPORTED THAT THE STAPLER RELEASED MULTIPLE CLIPS AT THE SAME TIME. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569551 VISISTAT 35R 6/BOX STAPLER GDT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1