BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 218362 · Received April 12, 1999

    Report

    Report Number
    1527736-1999-02077
    Event Type
    Death
    Date Received
    April 12, 1999
    Date of Event
    March 13, 1999
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A TOTAL GASTRECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT A POUCH WAS FORMED USING A TLC55 WITH DUODENAL TISSUE, THEN THE TISSUE APPROXIMATED WITH THE LOWER END OF THE ESOPHAGUS. THE CDH25 WAS INSERTED INTO THE LUMEN OF THE PROPOSED ANASTOMOSIS AND CLOSED DOWN TO 1MM STAPLE HEIGHT, SAFETY CATCH REMOVED AND FIRED. WHEN THE STAPLER WAS REMOVED, THE ANASTOMOSIS WAS CUT (FULL DOUGHNUTS FORMED), BUT NO STAPLES WERE PRESENT IN THE STAPLER. THE PROCEDURE WAS THEN CONTINUED BY HAND, LEADING TO A FURTHER 2 HOURS OF OPERATING TIME. ALSO DAMAGE TO THE DISTAL END OF THE ESOPHAGUS. THE PT WAS SENT TO THE HIGH DEPENDENCY UNIT, DEVELOPED CHEST PROBLEMS AS A RESULT OF THE EXTRA OPERATING TIME AND SUBSEQUENTLY DIED ON SATURDAY 3/13/1999. A POSTMORTEM EXAMINATION IS TO BE CARRIED OUT ON 3/17/1999. ON 03/25/1999 CO SPOKE WITH DR, THE SURGEON INVOLVED WITH THE ABOVE CASE. HE WAS GLAD THAT CO CALLED AND VERY INFORMATIVE REGARDING THE PARTICULARS AND OUTCOME FOR THIS PT. THE PT WAS AN ELDERLY MALE, WITH THE UNUSUAL FINDING OF TWO GASTRIC TUMORS, ONE DISTAL AND ONE IN THE PROXIMAL CARDIA. A TOTAL GASTRECTOMY WAS PERFORMED WITH THE CREATION OF A HUNT-LAWRENCE JEJUENAL POUCH. THIS WAS TO BE ANATOMOSED TO THE DIGITAL ESOPHAGUS USING THE CDH25 CIRCULAR STAPLER. BECAUSE THEY WERE WORKING TRANS-ABDOMINALLY, HIGH IN THE HIATUS, TRACTION SUTURES WERE PLACED IN THE ESOPHAGUS TO RETRACT THE DISTAL END INTO THE ABDOMINAL CAVITY. THE PURSE-STRING WAS EASILY APPLIED, BUT THE TRACTION SUTURES WERE CUT IN ORDER TO ATTACH THE ANVIL TO THE STAPLING DEVICE. THE STAPLER WAS THEN CLOSED TO THE GREEN INDICATOR LINES AND FIRED. DR REPORTED A NORMAL FEEL UPON FIRING THE INSTRUMENT WITH THE EXPECTED "CRUNCH." UNFORTUNATELY, UPON RELEASING THE STAPLER, THE ANASTOMOSIS IMMEDIATELY DISPRUPTED. ALTHOUGH THERE WERE TWO WELL DEFINED DONUTS IN THE STAPLER, THERE WERE NO STAPLES SEEN EITHER IN THE DONUTS, OR THE INTRA-ABDOMINAL TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA L4C24P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death