BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 8446415 · Received March 22, 2019

    Report

    Report Number
    2647580-2019-01550
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    February 18, 2018
    Report Date
    March 22, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE SAFETY AND FEASIBILITY OF LAPAROSCOPIC GASTRECTOMY ACCOMPANIED BY D1+ LYMPH NODE DISSECTION FOR EARLY GASTRIC CANCER IN ELDERLY PATIENTS SOURCE ASIAN JOURNAL OF ENDOSCOPIC SURGERY. ASIAN J ENDOSC SURG 12 (2019) 51¿57. RECEIVED 19 JUNE 2017; REVISED 25 JANUARY 2018; ACCEPTED 18 FEBRUARY 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY, THERE WERE 221 PATIENTS WHO UNDERWENT LAPAROSCOPIC GASTRECTOMY FOR EARLY GASTRIC CANCER DURING A 5 YEAR PERIOD (JANUARY 2010 TO DECEMBER 2014). THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ELDERLY PATIENTS (=75 YEARS OLD) AND YOUNGER PATIENTS ( <(><<)>75 YEARS OLD). OPEN CONVERSIONS WERE NECESSARY IN THE ELDERLY GROUP IN TWO CASES BECAUSE OF INTRAOPERATIVE FINDINGS OF SUSPICIOUS ADVANCED CANCER AND IN ONE CASE BECAUSE OF SPLENORRHAGIA. CONVERSIONS IN YOUNGER GROUP WERE NEEDED IN TWO CASES BECAUSE INTRAOPERATIVE FINDINGS OF SUSPICIOUS ADVANCED CANCER, ONE CASE BECAUSE OF SEVERE ADHESION, AND ONE CASE BECAUSE OF TECHNICAL DIFFICULTY DURING ESOPHAGOJEJUNOSTOMY. FOR ROUX-EN Y RECONSTRUCTION, WE INITIALLY APPLIED A TRANSORAL METHOD WITH ORAL ANVIL TO ESOPHAGOJEJUNOSTOMY UNTIL JULY 2014. POSTOPERATIVE COMPLICATIONS INCLUDED PANCREATIC FISTULA, POST- OPERATIVE BLEEDING, ANASTOMOTIC LEAKAGE, SURGICAL-SITE INFECTION, OBSTRUCTIVE ILEUS, INTRA-PERITONEAL ABSCESS, AND PNEUMONIA. A TOTAL OF 9 ELDERLY PATIENTS REQUIRED ADDITIONAL EMERGENT SURGERIES TO TREAT URGENT COMPLICATIONS DURING THE LONG-TERM POSTOPERATIVE PERIOD. INCISIONAL HERNIA, INTERNAL HERNIA, INTESTINAL VOLVULUS, ACUTE CHOLECYSTITIS, AND OTHER COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237789 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R