BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER 35R

    MDR report key: 1791946 · Received August 4, 2010

    Report

    Report Number
    3003898360-2010-00355
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 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

    EVALUATION: METHOD: DHR REVIEW PERFORMED. RESULTS: DHR REVIEW SHOWED THAT NO SIMILAR DEFECT WAS REPORTED DURING THAT MANUFACTURING OR PACKAGING PROCESSES OF THIS LOT. THE PROVIDED PICTURE OF THE DEVICE SHOWED THAT THE STAPLES WERE NOT FORMING PROPERLY. THE ROOT CAUSE IS LISTED AS MANUFACTURING PROCESSES. CONCLUSION: CAPA (B)(4) WAS OPENED TO ADDRESS THE ISSUE OF STAPLES NOT FORMING. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: STAPLES WERE NOT FORMING PROPERLY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER 35R SKIN STAPLER GDT TELEFLEX MEDICAL NA 01B1000404

    Patients

    Seq Age Sex Outcome Treatment
    1