BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 2062527 · Received March 21, 2011

    Report

    Report Number
    3003898360-2011-00103
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 8, 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

    EVALUATION: CONCLUSION: CAPA# (B)(4) WAS OPENED TO ADDRESS THIS ISSUE OF JAMMING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE STAPLER JAMMED DURING USE. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK