BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35R

    MDR report key: 2062093 · Received March 16, 2011

    Report

    Report Number
    3003898360-2011-00090
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: DEVICE HISTORY RECORD (DHR) PERFORMED. RESULTS: DHR REVIEW SHOWED THAT NO SIMILAR ISSUES WERE FOUND DURING MFG OR PACKAGING PROCESSES OF THIS LOT. CONCLUSIONS: CAPA (B)(4) WAS OPENED TO ADDRESS THE ISSUE OF STAPLES NOT FORMING PROPERLY. IF ADDITIONAL INFO IS RECEIVED ON THIS COMPLAINT, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHEN THE TRIGGER WAS DEPRESSED, SOME RESISTANCE WAS FELT AND STAPLES WERE NOT FORMED CORRECTLY DURING AN ORTHOPEDIC SURGERY. THIS EVENT CAUSED NO HARM TO THE PT. THE PROCEDURE WAS CONTINUED USING ANOTHER VISISTAT STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35R VISISTAT SKIN STAPLER GDW TELEFLEX MEDICAL NA 01D1000160

    Patients

    Seq Age Sex Outcome Treatment
    1