BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 45 MM STAPLE LINE 3.5 MM STAPLE LEG L

    MDR report key: 1022740 · Received March 25, 2008

    Report

    Report Number
    1527736-2008-01837
    Event Type
    Death
    Date Received
    March 25, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/25/2008. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED; HOWEVER, THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE, THIS DAMAGE IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE PROPER B-FORMED SHAPE. WE HAVE DOCUMENTED THE CIRCUMSTANCES THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, THE TRIGGER LOCKED WHEN IT WAS FIRED. THE PATIENT EVOLVED TO A DEEP VENOUS THROMBOSIS ONE DAY POST-OP, DIGESTIVE FISTULA, WITH THE NEED FOR A LAPAROTOMY 5 DAYS POST-OP. THE PATIENT EXPIRED. THE PHYSICIAN DOES NOT RELATE THE DIGESTIVE FISTULA TO THE PROBLEM PRESENTED BY THE DEVICE. HE THINKS THE DEATH WAS RELATED TO THE DECREASED VASCULARIZATION IN THE GASTRIC PROXIMAL REGION, AS IT HAPPENS IN MOST OF FISTULA CASES IN PROCEDURES LIKE THESE. THEREFORE, THE PHYSICIAN THINKS THE INITIAL DEEP VENOUS THROMBOSIS WAS THE PRIMARY REASON FOR THE THROMBOEMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 45 MM STAPLE LINE 3.5 MM STAPLE LEG L GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4GE15

    Patients

    Seq Age Sex Outcome Treatment
    1 Death