BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER

    MDR report key: 1881979 · Received October 12, 2010

    Report

    Report Number
    3003898360-2010-00434
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: NO SIMILAR DEFECT WAS REPORTED DURING THE MANUFACTURING OR PACKAGING PROCESSES OF THIS LOT. CONCLUSIONS: NO SOURCE OF FAILURE CAN BE DETERMINED WITHOUT DEFECTIVE SAMPLE. CAPA (B)(4) WAS ISSUED TO ADDRESS ISSUE. PRODUCTION PERSONNEL WERE NOTIFIED OF THE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE STAPLES DO NOT CLOSE. THE STAPLES REMAIN OPEN. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA 01M0900144

    Patients

    Seq Age Sex Outcome Treatment
    1