BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC SCALPEL DEVICE

    MDR report key: 285614 · Received July 13, 2000

    Report

    Report Number
    1527736-2000-03105
    Event Type
    Death
    Date Received
    July 13, 2000
    Report Date
    June 16, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DIRECTOR OF EES REGULATORY THE FOLLOWING INFO WAS OBTAINED FROM THE MINUTES OF THE GENERAL AND PLASTIC SURGERY DEVICES PANEL ON WEDNESDAY JUNE 16, 1999. THE ADVISORY PANEL COVERED AN INVESTIGATIONAL STUDY WITH THE INTUITIVE COMPANY'S INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM. IT WAS REPORTED THE HARMONIC SCALPEL WAS USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE BETWEEN JULY 1998 AND OCTOBER 1998. IT WAS REPORTED THE DEVICE WAS USED DURING AN INVESTIGATIONAL STUDY ON PT (THE PT WAS IN THE CONTROL GROUP). IT WAS REPORTED THERE WAS AN UNRECOGNIZED INJURY TO THE STOMACH DURING THE PROCEDURE WHICH WAS THOUGHT TO BE RELATED TO THE HARMONIC SCALPEL DEVICE. THIS INJURY WAS FOUND 24 HOURS POST-OPERATIVELY. THE PT HAD A GASTRIC PERFORATION FOLLOWED BY MULTIPLE REOPERATIONS AND EVENTUALLY DEVELOPED ARDS. THE PT EXPIRED ON THE 83RD POST-OPERATIVE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL DEVICE UNK GEI ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death