BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 81172 · Received January 6, 1997

    Report

    Report Number
    1527736-1997-00003
    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
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D6: DEVICE RETURNED WITH NO LOT # INFO. CONCLUSION: AB) BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING AND WITHIN DESIGN SPECS. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION AND WAS EXAMINED AND WAS FOUND TO BE FUNCTIONAL AND WITHIN DESIGN SPECS. COMMENTS: AB) EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IF FUNCTIONS PROPERLY. THE DIAMETER OF THE SHAFT HAS BEEN MODIFIED TO ACCOMODATE THE NEW OLYMPUS 5.4 MM SCOPE.

    Description of Event or Problem · 1

    THE DEVICES WERE USED IN A RIGHT HEMICOLECTOMY. DURING THE PROCEDURE, A TLC55 WITH TWO TCR55 RELOADS LOT NUMBER J4527G AND A TX60B WERE USED FOR THE ANASTOMOSIS. PT WAS READMITTED FOUR DAYS LATER 12/10/96, FOR THREE OR FOUR UNITS OF BLOOD. PT IS DOING FINE AT THIS TIME. 12/12/96 1155 - SURGEON CALLED AND SAID HE WAS DOING A NON COMPLICATED HEMICOLECTOMY ON A 70 YEAR 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, 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, PT EXPERIENCED ARRHYTHMIAS. PT WAS TRANSFUSED WITH THREE UNITS OF BLOOD AND SPENT TWO DAYS IN THE ICU. HE WAS BEING SENT HOME TODAY, 12/12/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER RELOADABLE LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J4427X

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention