BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CIRCULAR STAPLERS

    MDR report key: 6987057 · Received October 30, 2017

    Report

    Report Number
    3005075853-2017-05737
    Event Type
    Injury
    Date Received
    October 30, 2017
    Report Date
    October 4, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE POST-OP ISSUES MENTIONED IN THE ARTICLE ARE RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: LAPAROSCOPY-ASSISTED PROXIMAL GASTRECTOMY WITH GASTRIC TUBE RECONSTRUCTION FOR EARLY GASTRIC CANCER. AUTHORS: RYUUSUKE AIHARA, ERITO MOCHIKI TETURO OHNO, MITUHIRO YANAI, YOSHITAKA TOYOMASU, KYOICHI OGATA, HIROYUKI ANDO, TAKAYUKI ASAO, HIROYUKI KUWANO. CITATION: SURG ENDOSC 2010; 24:2343¿2348. DOI 10.1007/S00464-010-0947-8. IN THIS REPORT, LAPAROSCOPY-ASSISTED PROXIMAL GASTRECTOMY (LAPG) AND GASTRIC TUBE RECONSTRUCTION USING A MINI-LOP RETRACTOR (MLR) IS DESCRIBED FOR THE TREATMENT OF EARLY GASTRIC CANCER. BETWEEN JUNE 2007 AND SEPTEMBER 2008, 14 PATIENTS [11 MALE, 3 FEMALE; MEAN AGE 62.2 (RANGE 48-71) YEARS UNDERWENT LAPG WITH GASTRIC TUBE RECONSTRUCTION. FOR THE SURGICAL PROCEDURE, THE GASTRIC BODY WAS DIVIDED WITH A LINEAR STAPLER DEVICE TO MAKE THE GASTRIC TUBE. AFTER THE DISSECTED LINE WAS CLOSED WITH 3-0 VICRYL, THE GASTRIC TUBE AND ESOPHAGUS WERE ANASTOMOSED BY A CIRCULAR STAPLER (CDH, 25MM, ETHICON) INTRODUCED THROUGH THE STUMP OF THE GASTRIC TUBE. POSTOPERATIVE EVENTS INCLUDE: REFLUX SYMPTOMS, ANASTOMOTIC STENOSIS AND ANASTOMOTIC LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767711 PROXIMATE ILS CIRCULAR STAPLERS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention