BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2150565 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02767
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION TO THE INFORMATION PROVIDED, ADDITIONAL QUESTIONS WERE ASKED ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011 AND NO MORE INFORMATION OTHER THAN WHAT WAS PROVIDED HAS BEEN RECEIVED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. 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 A RECTO-SIGMOIDECTOMY, CYSTECTOMY, AND RADICAL PROSTATECTOMY PROCEDURE, AT THE MOMENT THAT THE DOCTOR WAS HOLDING THE COLORECTAL TO INITIATE THE ANASTOMOSIS, THE FIRST STAPLER TRIGGER BROKE. THE DOCTOR PERFORMED THE SURGERY, BUT, DUE TO THE STAPLER THAT BROKE, THEY OPTED TO NOT PERFORM THE ANASTOMOSIS. UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PIECES FELL INTO THE PATIENT. THE HOSPITALIZATION TIME DID NOT INCREASE DUE TO THIS EVENT. IT WAS NECESSARY TO PERFORM A BLOOD TRANSFUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U922

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE