BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1911170 · Received November 30, 2010

    Report

    Report Number
    3005075853-2010-06759
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT THE HOMEPATIENT (HP) DISCONNECTED FOR 10 MINUTES AND DID NOT CAP OFF THE PATIENT LINE WITH FLEXI CAP AND RECONNECTED. NOW HAS A CHECK PATIENT LINE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP HE SHOULD NOT HAVE RECONNECTED. THE TSR ADVISED THE HP THAT THE LINE MAY BE UNSTERILE AND THEY RUN A RISK OF INFECTION. THE TSR ADVISED THE HP TO CONTACT THE NURSE. THE TSR ADVISED THE HP WHEN STARTING OVER WITH NEW SUPPLIES WILL NEED NEW CASSETTE AND NEW BAGS. FOLLOW UP WITH THE NURSE REVEALED THAT SHE WAS NOT AWARE OF ANY PROBLEMS. SHE STATED THE HP HAD BEEN IN AND DIDN'T MENTION ANYTHING ABOUT THE REPORTED PROBLEM. SHE STATED HE WAS CURRENTLY USING THE CYCLER FOR THERAPY WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING, ONLY PART OF THE TISSUE WAS ANASTOMOSED; NO OTHER STAPLES CAME OUT. THE SURGEON USED HAND SEWING AND SWITCHED TO ANOTHER (B)(4) TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    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 CARTRIDGE