BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON*FLEX60

    MDR report key: 1723511 · Received June 15, 2010

    Report

    Report Number
    3005075853-2010-03210
    Event Type
    Death
    Date Received
    June 15, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A GOLD, PARTIALLY FIRED CARTRIDGE RELOAD LOADED ON THE DEVICE. A SECOND GOLD, PARTIALLY FIRED RELOAD CARTRIDGE WAS ALSO PRESENT IN A SEPARATE BAG. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOADS AND ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE KNIFE HAD SMALL NICKS. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. BATCH HISTORY REVIEW HAS BEEN COMPLETED WITH NO ANOMALIES REPORTED.

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL FOLLOWUP: THE REP WAS ADVISED THAT THE RESIDENT FIRED THE DEVICE, AND THE REP CONFIRMED THE RESIDENT HAS BEEN INSERVICED AND HAS USED IT BEFORE. IT IS UNKNOWN IF AN AUTOPSY WILL BE PERFORMED OR IF A VASCULAR SURGEON WAS CALLED INTO THE CASE. PATIENT WAS A (B) (6) MALE, (B) (6). PREEXISTING CONDITIONS INCLUDE HYPERTENSION, CANCER AND PATIENT WAS TAKING A BETA BLOCKER, THE PATIENT WAS NOT ON COUMADIN. SURGEON INDICATED TO THE REP THAT IT IS UNKNOWN IF THE BLEEDING WAS FROM THE STAPLE LINE OR THE DEFECT IN THE PULMONARY ARTERY. THE SURGEON IS CONTINUING TO USE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT LOWER LOBECTOMY PROCEDURE. THE TUMOR WAS LOCATED MIDLINE NEAR THE MEDIASTINUM, AND THE SURGEON UTILIZED A LATERAL APPROACH TO RESECT THE TUMOR. THE FIRST AND SECOND FIRINGS WERE PERFORMED WITH GOLD CARTRIDGES WITH NO DIFFICULTY. THE PULMONARY ARTERY AND PULMONARY VEIN WERE DISSECTED IN ORDER TO MOBILIZE THE LUNG AND TUMOR. REP WAS ADVISED THAT WHILE DOING THIS THE PULMONARY ARTERY WAS NICKED. A CLAMP WAS PLACED ON THE PULMONARY ARTERY, THE ARTERY WAS THEN SUTURED AND THE CLAMP WAS NOT REMOVED AT THIS TIME. THE DEVICE FOR THE THIRD FIRING AND ACCORDING TO THE OR PERSONNEL ALL FOUR STROKES WERE FIRED BUT THE DEVICE WOULD NOT OPEN. THE SALES REP WAS CALLED ON THE PHONE AND AFTER CONFIRMING ALL STROKES HAD BEEN FIRED, HE DIRECTED THEM TO ACTIVATE THE RED BUTTON TO RELEASE THE DEVICE WHICH WAS SUCCESSFUL IN OPENING THE DEVICE. THE DEVICE AND THE CLAMP FROM THE PULMONARY ARTERY WERE REMOVED AT THE SAME TIME, IMMEDIATE BLEEDING OCCURRED. IT COULD NOT BE CONFIRMED WHERE THE BLEEDING WAS COMING FROM AND ULTIMATELY, THE BLEEDING COULD NOT BE CONTROLLED AND THE PATIENT EXPIRED INTRAOPERATIVELY.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) CONTACTED CORPORATE BAXTER PRODUCT SURVEILLANCE ON FRIDAY, (B)(6) 2010 TO REPORT A SECOND OR THIRD BAG FALLING OFF THAT WAS HOOKED UP TO THE HOMECHOICE (HC) CYCLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THIS MEDICAL DEVICE REPORT IS AGAINST THE CASSETTE FOR THE SEPARATED CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death RELOAD-ECR60D