BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W SKIN STAPLER

    MDR report key: 903283 · Received August 22, 2007

    Report

    Report Number
    3003898360-2007-00068
    Event Type
    Malfunction
    Date Received
    August 22, 2007
    Date of Event
    January 1, 2006
    Report Date
    July 24, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN 2006, TELEFLEX MEDICAL WAS NOTIFIED IN JULY 2007. THE ACTUAL DEVICE HAS NOT BEEN INVESTIGATED AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR REPORTED THIS ISSUE TO TELEFLEX MEDICAL ON 7/24/2007. THE CONDITION OCCURRED IN 2006. THE FACILITY ALLEGES THE STAPLER JAMMED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT 35W SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 1996689

    Patients

    Seq Age Sex Outcome Treatment
    1 YR