BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1074359 · Received July 11, 2008

    Report

    Report Number
    3005075853-2008-00428
    Event Type
    Death
    Date Received
    July 11, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. 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 LAP LEFT HEMICOLECTOMY PROCEDURE, THERE WERE NO ISSUES WITH THE DEVICE. IMMEDIATELY POST OPERATIVELY, THE PATIENT WAS STABLE. TWENTY-EIGHT HOURS LATER, THE PATIENT DIED FOLLOWING A BLOOD LEAK FROM THE ANASTOMOTIC SITE. IT IS UNKNOWN IF A LEAK TEST WAS PERFORMED AT THE ANASTOMOTIC SITE DURING THE PROCEDURE. IT IS BELIEVED THAT THE PATIENT WAS NOT ON ANY ANTICOAGULANTS PRE-OP. THE PATIENT WAS IN THE HOSPITAL AND WAS NOT TAKEN BACK TO SURGERY PRIOR TO HIS DEATH. AN INITIAL AUTOPSY REPORT MENTIONED BLOOD IN THE COLON FROM A BLOOD LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM OCW ETHICON ENDO-SURGERY, LLC NA D4J771

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death