BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK VISISTAT SKIN STAPLER

    MDR report key: 2080641 · Received April 25, 2011

    Report

    Report Number
    3003898360-2011-00181
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    October 6, 2010
    Report Date
    March 31, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED. RESULTS: THE DHR REVIEW SHOWED THAT NO SIMILAR ISSUES WERE FOUND DURING THE MFG OR PACKAGING PROCESSES OF THIS LOT. CONCLUSIONS: (B)(4) WAS OPENED TO ADDRESS THE ISSUE OF STAPLES JAMMING. IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DEVICE WAS JAMMING DURING USE ON A PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 01M0900143

    Patients

    Seq Age Sex Outcome Treatment
    1