BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVE CUTTER STAPLER

    MDR report key: 2213951 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03336
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WERE PROBLEMS WITH TWO DEVICES. FIRST DEVICE - THE DEVICE WAS CLOSED, BUT THE FIRING LEVER WOULD NOT CLOSE PLASTIC TO PLASTIC. THE PIN WAS SEATED. NO CUT OCCURRED AND NO STAPLES WERE DEPLOYED. ANOTHER DEVICE WAS OPENED. SECOND DEVICE - DEVICE WAS CLOSED AND DEVICE WAS FIRED PLASTIC TO PLASTIC. STAPLES DID NOT FORM B-SHAPE. THE INCISION WAS SUTURED CLOSED. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS DELAYED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVE CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE