BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 310989 · Received January 3, 2001

    Report

    Report Number
    1527736-2001-00010
    Event Type
    Death
    Date Received
    January 3, 2001
    Report Date
    December 6, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WERE USED DURING A LAPAROSCOPIC SPLENECTOMY. THE REP REPORTED THE PT BLED OUT AND DIED 18 DAYS POST OPERATION. APPARENTLY AN AUTOPSY WAS PERFORMED TO IDENTIFY CAUSE OF DEATH: MAJOR HEMOPERITONEUM. THERE WAS NO KNOWN INSPECTION OF THE STAPLE LINES OR TREATED AREAS. SURGEON TOLD THE REP "THEY DID NOT SEE THE STAPLE LINES." REP WAS TOLD BY THE MD THE PT HAD OTHER MEDICAL PROBLEMS GOING ON; PT EXPIRED AT HOSP AND WAS HOSPITALIZED ACCORDING TO SURGEON "FOR OTHER REASONS." SURGEON STATED THE CASE WAS UNEVENTFUL. SURGEON USED HARMONIC SCALPEL, LCSC5, ON THE SHORT GASTRICS, AND 3 FIRINGS OF ATW45 DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359 HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES-ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death