BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 1900417 · Received October 27, 2010

    Report

    Report Number
    3003898360-2010-00463
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 13, 2010
    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 RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE WAS SOME RESISTANCE WHEN THE HANDLE WAS DEPRESSED AND STAPLES WERE NOT FORMED CORRECTLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 01A1000394

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK