BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT 35W 6/BOX

    MDR report key: 2833849 · Received November 7, 2012

    Report

    Report Number
    3003898360-2012-00515
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 19, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAM OF PHOTO DID NOT REVEAL ANY DEFECT. NO ACTUAL SAMPLE TO EVALUATE. DHR REVIEW DID NOT REVEAL ANY ISSUES RELATED TO THIS COMPLAINT. FROM THE PHOTO THE REPORTED DEFECT WAS NOT OBSERVED. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATED DEFECT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: THE STAPLER JAMMED DURING USE IN THE PROCEDURE. THE EVENT CAUSED NO HARM TO THE PT. ANOTHER STAPLER WAS RETURNED TO CONTINUE THE PROCEDURE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT 35W 6/BOX SKIN STAPLER GDT TELEFLEX MEDICAL 01H1100049

    Patients

    Seq Age Sex Outcome Treatment
    1