BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2800415 · Received October 22, 2012

    Report

    Report Number
    3005075853-2012-04812
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION PROVIDED: WHO FIRED THE DEVICE, THE SURGEON OR SOMEONE ELSE? SURGEON. WAS THE SALES PRESENT AS THE INCIDENT OCCURRED? YES. WAS THE USER TRAINED? YES. HOW OFTEN HAS THIS PERSON USED THE DEVICE? NUMEROUS TIMES. ON WHICH FIRING(S) DID THIS EVENT OCCUR? THE 1ST. GENERALLY THIS INSTRUMENT IS ONLY FIRED ONCE DURING PROCEDURE. IF NOT THE FIRST FIRING, WERE THERE ANY PROBLEMS RELOADING THE DEVICE? NO. AFTER THE CLOSURE TRIGGER WAS ADVANCED, DID THE SURGEON REPOSITION THE TISSUE? YES. DID THE SURGEON INADVERTENTLY GRASP THE FIRING TRIGGER PRIOR TO FIRING THE INSTRUMENT? NO. WAS THE CLOSURE TRIGGER LATCHED PRIOR TO FIRING THE DEVICE? YES. WAS THE SURGEON ABLE TO CONFIRM THAT THE INTENDED TISSUE WAS IN THE CLOSED JAWS OF THE INSTRUMENT PRIOR TO FIRING? YES. WAS THE TISSUE EVENLY DISTRIBUTED WITHIN THE JAWS OF THE INSTRUMENT? YES. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. DID THE SURGEON REALLY SEE ANY STAPLES AT ALL OR WERE THERE ONLY A FEW? NO STAPLES PRESENT. AFTER PROCEDURE HE SPOKE WITH HIS COLLEAGUES TO CONFIRM THAT THERE WERE NO LOOSE STAPLES IN BOWEL EITHER.

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. WE DID NOT RECEIVE A BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUB TOTAL COLECTOMY PROCEDURE, SCRUB NURSE REMOVED THE STAPLE RETAINING COVER AND HANDED THE DEVICE TO THE SURGEON, THE SURGEON FIRED THE DEVICE ACROSS THE TISSUE ON THE LOWER RECTAL AREA. THE STAPLES FORMED A STAPLE LINE ON THE SPECIMEN SIDE THAT WAS BEING REMOVED. HOWEVER, THERE WAS NO STAPLE LINE FORMED ON THE PATIENT SIDE. THE SURGEON HAD TO SUTURE THE TISSUE CLOSED IN ORDER TO CONTINUE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1