BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT 35R 6/BOX

    MDR report key: 3896462 · Received May 16, 2014

    Report

    Report Number
    3003898360-2014-00306
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE WAS NOT RETURNED TO MANUFACTURER. NO LOT # AVAILABLE. A VISUAL OR FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. 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 MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: THE STAPLER HAS STAPLES IN THE CARTRIDGE, BUT IT IS NOT FIRING. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294598 WECK VISISTAT 35R 6/BOX SKIN STAPLER GAG TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1