BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE LINEAR CUTTER RELOADING UNIT WITH SAFETY LOCK

    MDR report key: 288348 · Received August 3, 2000

    Report

    Report Number
    1527736-2000-03533
    Event Type
    Death
    Date Received
    August 3, 2000
    Date of Event
    June 9, 2000
    Report Date
    July 10, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT (1) TLC75 AND (1) TCR75 WERE USED DURING A LAPAROSCOPIC POSTERIOR WALL OF STOMACH PROCEDURE. IT WAS REPORTED BY THE REP THAT IN 2000 THE PT WAS PRESENTED TO THE EMERGENCY ROOM WITH ACUTE ABDOMINAL PAIN DUE TO PERFORATION OF POSTERIOR WALL OF STOMACH, AND A LAPAROTOMY OF POSTERIOR WALL OF STOMACH WAS PERFORMED USING THE TLC75 AND TCR75 MENTIONED ABOVE. NINE DAYS LATER THE PT RETURNED TO PRE AND POST-OP DUE TO AN ABDOMINAL MASS. ABDOMINAL EXPLORATION WAS PERFORMED, RESULTING IN A LIVER BIOPSY: NO INSTRUMENTS WERE USED. TWO DAYS LATERON THE PT RETURNED FOR ABDOMINAL DRAINAGE OF THE ORIGINAL RESECTION SITE. AN EXPLORATORY LAPAROSCOPY WITH THE INSERTION OF A JEJUNOSTOMY TUBE WAS PERFORMED. THREE DAYS LATER THE PT RETURNED FOR ANOTHER EXPLORATORY LAPAROSCOPY WHICH REVEALED AN INFECTION AT ABDOMINAL INCISION DUE TO SMALL BOWEL INFARCTION. IT WAS NOT KNOWN AT THE TIME OF THIS REPORT WHY OR WHEN THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER RELOADING UNIT WITH SAFETY LOCK LINEAR CUTTERS - CONVENTIONAL GCJ ETHICON ENDO-SURGERY, INC. NA M4G47Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death