BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 1931155 · Received November 15, 2010

    Report

    Report Number
    3003898360-2010-00473
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 27, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO MFR AT TIME OF THIS REPORT; THEREFORE, INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE STAPLER JAMMED DID NOT RELEASE THE STAPLES WHEN TRIGGER WAS SQUEEZED DURING TREATMENT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 01B1000403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK