BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 3912420 · Received May 13, 2014

    Report

    Report Number
    3003898360-2014-00309
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 17, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MFR. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A VISUAL AND FUNCTIONAL INVESTIGATION COULD NOT BE PERFORMED SINCE NO DEVICE WAS NOT RETURNED FOR INVESTIGATION. COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE. FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: THE SKIN STAPLER DID NOT WORK. SYSTEM WAS JAMMED. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285629 VISISTAT 35R 6/BOX SKIN STAPLER GAG TELEFLEX 01G1300385

    Patients

    Seq Age Sex Outcome Treatment
    1