BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 3131802 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02614
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    November 16, 2012
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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 IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: IT WAS REPORTED THAT AFTER A LAP ASSISTED DISTAL GASTRECTOMY, BLEEDING IN A DRAIN WAS CONFIRMED ON POSTOPERATIVE DAY 1. THE BLEEDING WAS ESTIMATED THAT IT WAS FROM THE ANASTOMOSIS PART AT THE 5TH FIRING BECAUSE THERE WAS BLEEDING EVIDENCE (LIKE A BLOOD CLOT ON THE STAPLE LINE) FROM THE ANASTOMOSIS PART THOUGH AN ENDOSCOPE. FOUR UNITS BLOOD INFUSION WAS PERFORMED AND STOPPING BLEEDING BY ITSELF WAS CONFIRMED THROUGH THE ENDOSCOPIC. THE STAPLE FORM WAS NOT CONFIRMED. NO REOPERATION WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON UNKNOWN DATE IN (B)(6) 2012. HOSPITALIZATION WAS AS SCHEDULED AND IT WAS NOT PROLONGED. THE CARTRIDGE COLOR WAS GREEN AND USED 3 CARTRIDGES DURING A DELTA ANASTOMOSIS. THE AMOUNT OF BLEEDING WAS UNKNOWN. REINFORCEMENT MATERIAL WAS NOT USED. IN THE FORMER PROCEDURE, THE TARGET TISSUE WAS SLIGHTLY THIN AND WAS CLAMPED UNIFORMLY BY THE DEVICE. THE DEVICE WAS NOT FIRED ACROSS SOMETHING HARD SUCH AS A CLIP OR AN EXISTING STAPLE LINE. THERE WAS NO AN EXPECTED RESISTANCE IN CLOSING AND AT FIRING. THE FIRING TRIGGER WAS GRASPED FULLY AT THE FIRING. THE STAPLES WERE FORMED AS INTENDED AS LONG AS THEY WERE CHECKED VISUALLY. THERE WERE NO ANOMALIES IN THE DEVICE¿S FUNCTION OF SUTURE AND OF CUTTING. NO LEAK AND NO BLEEDING WERE CONFIRMED VISUALLY PRIOR TO THE END OF THE FORMER PROCEDURE. THE DOCTOR COMMENTED THAT THE POSTOPERATIVE BLEEDING MIGHT HAVE BEEN ATTRIBUTED TO AN UNFIRM STAPLE FORM BECAUSE THE BLEEDING HAD BEEN FROM THE ANASTOMOSIS SITE. THE PATIENT BACKGROUND (INITIAL, AGE, SEX, WEIGHT, CURRENT ILLNESS AND PREVIOUS ILLNESS) WERE NOT PROVIDED. NO DEVICE WILL BE RETURNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, BLEEDING AT THE ANASTOMOSIS PART AT THE 5TH FIRING WAS CONFIRMED ON POSTOPERATIVE DAY 1. BLOOD INFUSION WAS PERFORMED AND STOPPING BLEEDING BY ITS SELF WAS CONFIRMED THROUGH THE ENDOSCOPIC. NO REOPERATION WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CARTRIDGE COLOR WAS GREEN AND USED THREE CARTRIDGES DURING A DELTA ANASTOMOSIS. THE AMOUNT OF BLEEDING AND OF BLOOD INFUSION WERE UNKNOWN. THE STAPLE FORM WAS UNKNOWN. REINFORCEMENT MATERIAL WAS NOT USED. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236804 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR45G (DISCARDED)