BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 2052134 · Received March 1, 2011

    Report

    Report Number
    3003898360-2011-00109
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Report Date
    February 28, 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

    EVAL: METHOD - COMPLAINT HISTORY REVIEW. RESULTS - ONE OTHER COMPLAINT WAS IDENTIFIED FOR THIS CATALOG NUMBER, FROM (B)(4) 2010 TO (B)(4) 2011. CONCLUSIONS - THE LOT NUMBER REPORTED WAS MANUFACTURED PRIOR TO CORRECTIVE ACTIONS DOCUMENTED IN CAPA (B)(4).

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE HANDLE DOES NOT GO BACK TO THE ORIGINAL POSITION DURING USE. THE REPORTED MAL-FUNCTION CAUSED A DELAY IN SURGERY TIME. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER SKIN STAPLER GDW TELEFLEX MEDICAL NA T1205143

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK