BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35R

    MDR report key: 2062091 · Received March 16, 2011

    Report

    Report Number
    3003898360-2011-00089
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED BY MFR, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT REPORTED AS: STAPLES DID NOT DETACH THEMSELVES SMOOTHLY FROM THE WIDE ANVIL. THE EVENT OCCURRED DURING USE IN AN UNK PROCEDURE, BUT CAUSED NO HARM TO THE PT. THE PROCEDURE WAS CONTINUED USING ANOTHER VISISTAT STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35R VISISTAT SKIN STAPLER GDW TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1