BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 275594 · Received April 28, 2000

    Report

    Report Number
    1527736-2000-01707
    Event Type
    Death
    Date Received
    April 28, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE (1) TLC55 AND THE (1) CDH29 WERE USED DURING A LOW ANTERIOR RESECTION AND END-TO-SIDE PROCEDURE. IT WAS REPORTD THAT THE ANASTOMOSIS WAS LEAK CHECKED. THE PT WAS REOPERATED ON AND THE STAPLE LINE WAS OPENED HALFWAY AROUND. THE PT HAS EXPIRED. THE BOWEL WAS SAVED AND WILL BE EXAMINED. NO INSTRUMENTS WERE LEFT FOR EXAMINATION. STAPLERS FROM THE BATCH LEFT AT THE HOSP WILL BE RETURNED. 04/04/2000: IT WAS REPORTED BY THE AFFILIATE THE TLC55 AND CDH29 WERE USED DURING BOWEL RESECTION. IT WAS REPORTED THE PT HAD CANCER IN THE LOWER PART OF THE SIGMOID COLON. THE CANCER WAS REMOVED BY AN END TO END ANASTOMOSIS. AN AIR LEAK TEST WAS PERFORMED AND THE DONUTS WERE INTACT. ON THE 4TH POSTOP DAY, THE PT WAS BROUGHT BACK TO THE OR AND A 180 DEGREE RUPTURE OF THE STAPLE LINE WAS DISCOVERED. THIS WAS CLOSED. THE PT WAS LATER PUT ON A RESPIRATOR AND DIED OF PERITONITIS ON 04/03/2000. A SMALL PIECE OF BOWEL HAS BEEN SAVED. THE REPS HAVE TAKEN THE SURGEON THROUGH THE FIRING STEPS OF THE DEVICES AND NOTICED THE SURGEON OPENED THE DEVICES WITH MORE THAN 1/2 TO 3/4 ROTATION AFTER FIRING. (1) CDH29 STERILE DEVICE OF THE SAME BATCH IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTERS-CONVENTIONAL GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death