BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R SKIN STAPLER

    MDR report key: 901572 · Received August 22, 2007

    Report

    Report Number
    3003898360-2007-00058
    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
    PMA / PMN Number
    NA
    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 RETURNED FOR EVAL. THE REPORTED CONDITION WAS INVESTIGATED AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AS OF JANUARY 31, 2007.

    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 PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT 35R SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 1996550

    Patients

    Seq Age Sex Outcome Treatment
    1 YR