BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 3140472 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02717
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED POST OP AN OPEN ILEUM STOMA CLOSING, THE PATIENT VOMITED BLOOD ON THE NEXT DAY. WHEN INSIDE THE GASTROINTESTINAL TRACT IT WAS CONFIRMED ORALLY WITH AN ENDOSCOPE, BLEEDING POINT COULD NOT BE FOUND. ACCORDING TO CT, IT WAS CONSIDERED THAT THERE WAS AN ANOMALY IN THE ANASTOMOSIS SITE AT THE 2ND FIRING. DURING AN EMERGENCY OPERATION ON (B)(6), WHEN NEAR THE ANASTOMOSIS SITE WAS A CUT; ARTERIOSUS BLEEDING WAS CONFIRMED FROM THE MIDDLE PART OF THE STAPLES CLOSEST TO THE CUT LINE ON THE ANASTOMOSIS SITE. THE COAGULUM WAS FORMED BY BLOOD FROM THERE. BECAUSE OF THE COAGULUM, BLOOD VOMITING WAS CONSIDERED THAT IT CAUSED, DEPENDING ON AN ILEUS CONDITION OF THE ANASTOMOSIS PART, THAT BLOOD DID NOT COME DOWN INSIDE THE LOWER GASTROINTESTINAL TRACT AND MELENA WAS NOT CONFIRMED, BUT FLOWED BACK UP. BLOOD AND CONTENT DID NOT LEAK INSIDE THE ABDOMEN. A FUNCTIONAL END-TO-END ANASTOMOSIS WAS PERFORMED WITH ENDO GIA (COVIDIEN). AMOUNT OF BLOOD INFUSION WAS 2 UNITS. AFTER AN EMERGENCY OPERATION, WHEN THE EXENTERATE SPECIMEN WAS CHECKED, STAPLES WHICH HAD BEEN DEPLOYED BY NTLC DURING FORMER PROCEDURE WERE FORMED AS INTENDED. THE TISSUE OF THE INTESTINAL TRACT¿S COLOR WAS GOOD AND NO ANOMALIES WERE CONFIRMED VISUALLY. DURING THE FORMER PROCEDURE, THE DEVICE WAS USED FOR A FUNCTIONAL END-TO-END ANASTOMOSIS ON THE ILEUM OF THE SMALL INTESTINE. TWO-FIRING METHOD WAS PERFORMED AND THE STAPLE HEIGHT WAS BLUE BOTH FOR AN ANASTOMOSIS AND FOR CLOSING. THE DOCTOR CONFIRMED THAT THE MESENTERIUM WAS NOT INVOLVED BY THE DEVICE AND S/HE REINFORCED THE CROTCH PART. THE STAPLES WERE FORMED AS INTENDED. THE DOCTOR COMMENTED THAT FAILURE OF THE SUTURES HAD NOT BEEN CONFIRMED AND BLEEDING WAS CHECKED BY WIPING WITH A SWAB SOON AFTER ANASTOMOSIS. THE TARGET TISSUE WAS THIN AND WAS CLAMPED UNIFORMLY BY THE DEVICE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240829 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention RELOAD SR75