BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 1881399 · Received October 7, 2010

    Report

    Report Number
    3003898360-2010-00435
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 17, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: NO SIMILAR DEFECT WAS REPORTED DURING THE MFG OR PACKAGING PROCESSES OF THIS LOT. CONCLUSIONS: OTHER - CAPA (B)(4) WAS ISSUED TO ADDRESS ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE STAPLER JAMMED DURING USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 01A1000394

    Patients

    Seq Age Sex Outcome Treatment
    1