BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 79019 · Received January 6, 1997

    Report

    Report Number
    1628808-1997-00002
    Event Type
    Injury
    Date Received
    January 6, 1997
    Date of Event
    December 6, 1996
    Report Date
    January 6, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICES WERE USED IN A RIGHT HEMICOLECTOMY. DURING THE PROCEDURE, A TLC55 WITH 2 TCR55 RELOADS LOT NUMBER J4527G AND A TX60B WERE USED FOR THE ANASTOMOSIS. THE PT WAS READMITTED FOUR DAYS LATER (12/10/96) FOR 3 OR 4 UNITS OF BLOOD. PT IS DOING FINE AT THIS TIME. ON 12/12/96 1155 - SURGEON CALLED AND SAID HE WAS DOING A NON COMPLICATED HEMICOLECTOMY ON A 70 YR OLD MALE. HE STAPLED THE ILEUS TO THE COLON WITH THE LINEAR CUTTER AND THEN CLOSED THE BOWEL WITH THE LINEAR STAPLER. AFTER CLOSING THE ANASTOMOSIS, THE SURGEON CHECKED THE STAPLE LINES AND THERE WAS NO BLOOD SEEN AND THE STAPLE LINES LOOKED FINE. TWO DAYS POST-OP, THE PT DEVELOPED A GI BLEED AND WAS ADMITTED TO THE ICU. ALONG WITH ANEMIA, THE PT EXPERIENCED ARRHYTHMIAS. THE PT WAS TRANSFUSED WITH 3 UNITS OF BLOOD AND SPENT TWO DAYS IN THE ICU. HE IS BEING SENT HOME TODAY, 12/12/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GCJ ETHICON ENDO-SURGERY, INC. NA J4557L

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention