BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 3851504 · Received March 25, 2014

    Report

    Report Number
    3003898360-2014-00202
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAG
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MANUFACTURER. PER DHR THE PRODUCT VISISTAT 35W 6/BOX, LOT #01M1200074 WAS MANUFACTURED ON 12/11/2012 A TOTAL OF 9,000 PIECES. LOT WAS RELEASED ON 12/13/2012. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. 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. WE WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: THE FACILITY REPORTED THAT THE STAPLER STOPPED FIRING STAPLES WHEN THEY WERE ABOUT A HALF WAY THROUGH THE SET OF STAPLES. PT CONDITION LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173911 VISISTAT 35W 6/BOX SKIN STAPLER GAG TELEFLEX MEDICAL 01M11200074

    Patients

    Seq Age Sex Outcome Treatment
    1