BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1904816 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06600
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE ECHELON FLEX WITH A GREEN CARTRIDGE WAS USED TO LIGATE THE VESSELS AND A "FANENSTIEL" WAS MADE AND THE CONTOUR WAS USED AS IT WAS SUCH A LOW TUMOR. THE CONTOUR WAS FIRED AS NORMAL AND THE DISTAL STAPLE LINE WAS FORMED AND THE SPECIMEN REMOVED. WHEN THE CDH WAS INSERTED AND POSITIONED, THE STAPLE LINE APPEARED TO `UNZIP ITSELF AND THEY THEN HAD TO ATTEMPT TO HAND-SEW THE ANASTOMOSIS BUT AS IT WAS SO LOW THEY ENDED UP HAVING TO PERFORM AN APR. RECOVERY TIME WILL BE MUCH LONGER DUE TO THE APR. UPON EXAMINATION OF THE STAPLE LINE, IT APPEARED THERE WAS ONLY ONE ROW OF STAPLES RATHER THAN TWO ON THE SPECIMEN. THE PROCEDURE WAS PROLONGED 120 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON 11/18/2010, 12/6/2010 AND 12/16/2010 AND NO MORE INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    SALES RECEIVED A PHONE CALL FROM THE HOSPITAL REPORTING AN EVENT THE OCCURRED DURING THE PREPARATION FOR SURGERY. DURING A CASE, THE PA WAS RINSING A VALVE IN SALINE, IT LOOKED LIKE THERE WERE "FUZZIES" COMING OFF OF THE LEAFLETS. THE PA SAID THAT THEY CLEANED IT UP, AND THAT [THE SURGEON] PULLED A FEW OFF WITH HIS PICK-UPS AND THEY IMPLANTED IT ]THE VALVE]. THEY SAID THAT THEY DIDN'T REALLY NOTICE IT UNTIL IT WAS PLACED IN SALINE. THE DEVICE WAS IMPLANTED WITH NO COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE