BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W SKIN STAPLER

    MDR report key: 1080286 · Received March 7, 2008

    Report

    Report Number
    3003898360-2008-00061
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Report Date
    July 3, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REQUESTED FOR EVAL. SAMPLE NOT RECEIVED AT TIME OF THIS REPORT. A COMPLETE REPORT WILL FOLLOW WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BLOCKING OF THE STAPLER BEFORE EVERY STAPLE INSTALLATION. NO PT AND/OR USER INJURY. NO MEDICAL /SURGICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT 35W SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 01A0800087

    Patients

    Seq Age Sex Outcome Treatment
    1