BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35W

    MDR report key: 2060854 · Received March 11, 2011

    Report

    Report Number
    3003898360-2011-00113
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 17, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE STAPLER JAMMED DURING A PROCEDURE. ANOTHER STAPLER WAS SUCCESSFULLY USED. NO PATIENT INJURY REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35W VISISTAT SKIN STAPLER GDT TELEFLEX MEDICAL NA 01F1000161

    Patients

    Seq Age Sex Outcome Treatment
    1