BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 1854294 · Received September 3, 2010

    Report

    Report Number
    3003898360-2010-00394
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO LOT NUMBER OR SAMPLE FOR REVIEW. CONCLUSIONS: CAPA (B)(4) WAS ISSUED TO ADDRESS THE ISSUE OF JAMMING. IF ADDITIONAL INFO IS RECEIVED FOR THIS COMPLAINT A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A VISISTAT STAPLER WAS JAMMED TO THE POINT THAT THE STAPLES WILL NOT RELEASE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1