BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX45

    MDR report key: 3072404 · Received April 23, 2013

    Report

    Report Number
    3005075853-2013-01921
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 22, 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 WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, BLEEDING FROM A DRAIN WAS CONFIRMED 5 HOURS AFTER THE OPERATION. WITH AN ENDOSCOPE, IT WAS FOUND THAT BLEEDING WAS FROM THE ANASTOMOSIS SITE BETWEEN THE STOMACH AND THE JEJUNUM AT THE 5TH FIRING. BLEEDING WAS STOPPED WITH A CLIP ENDOSCOPICALLY AND ORALLY AND NO REOPERATION WAS PERFORMED. NO OTHER TREATMENTS FOR STOPPING BLEEDING WERE PERFORMED. BLOOD INFUSION WAS PERFORMED. AMOUNT OF BLEEDING AND OF BLOOD INFUSION WERE UNKNOWN. BLEEDING WAS CONSIDERED ARTERIOSUS. DURING AN ENDOSCOPIC OBSERVATION, IT WAS CHECKED THAT THE STAPLES WERE DEPLOYED, BUT THE STAPLE FORM WAS NOT CHECKED. THE PATIENT HAS ALREADY BEEN DISCHARGED FROM THE HOSPITAL IN THE WEEK OF (B)(6). HOSPITALIZATION PERIOD WAS AS SCHEDULED AND WAS NOT PROLONGED. THERE WERE NO PROBLEMS IN THE FORMER OPERATION AND NO ANOMALIES IN BOTH SUTURING AND CUTTING FUNCTIONS OF THE DEVICE. THE TARGET TISSUE WAS THIN. THE TARGET TISSUE WAS CLAMPED WITH THE JAWS UNIFORMLY. THE DEVICE WAS NOT FIRED ACROSS SOMETHING HARD. THERE WAS NO UNEXPECTED RESISTANCE IN CLOSING AND AT FIRING. THE FIRING TRIGGER WAS GRASPED FULLY AT FIRING. THE STAPLES WERE FORMED AS INTENDED. AFTER THE DEVICE WAS FIRED FOR ANASTOMOSIS BETWEEN THE STOMACH AND THE JEJUNUM, THE ANASTOMOSIS SITE WAS CHECKED VISUALLY SEVERAL TIMES UNTIL CLOSING THE ABDOMEN AND NO LEAK AND NO BLEEDING WERE CONFIRMED. FOR ANASTOMOSIS, GOLD CARTRIDGE WAS USED. REINFORCEMENT MATERIAL WAS NOT USED. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173486 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR45D (DISCARDED)