BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX ACCESS 55MM ART STAP THIC

    MDR report key: 2170444 · Received July 21, 2011

    Report

    Report Number
    3005075853-2011-02912
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A VALID BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLON RESECTION PROCEDURE, THE STAPLES DID NOT DEPLOY. A SECOND DEVICE WAS USED AND THE STAPLES DID NOT DEPLOY EITHER. FINALLY A CONTOUR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX ACCESS 55MM ART STAP THIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA E4UH9M

    Patients

    Seq Age Sex Outcome Treatment
    1