BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JVAC UNKNOWN PRODUCT

    MDR report key: 7307804 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71179
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    JOL
    PMA / PMN Number
    K953655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/9/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: WORLD JOURNAL OF SURGICAL ONCOLOGY 2015; 13:181. DOI: 10.1186/S12957-015-0591-9.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: SIGNIFICANCE OF PROPHYLACTIC INTRA-ABDOMINAL DRAIN PLACEMENT AFTER LAPAROSCOPIC DISTAL GASTRECTOMY FOR GASRIC CANCER IN GASTRIC SURGERY, DRAIN PLACEMENT IS DESIGNED FOR THE REMOVAL OF FLUID COLLECTIONS OR FOR THE EARLY DETECTION OF POSTOPERATIVE BLEEDING, PANCREATIC FISTULAS, ANASTOMOTIC LEAKAGE, AND INTRA-ABDOMINAL INFECTIONS. INCORRECT USE OF AN INTRA-ABDOMINAL DRAIN CAN CAUSE EXUDATION OF PROTEIN-RICH ASCITIC FLUID, WHICH MAY LEAD TO HYPOVOLEMIA AND HYPOPROTEINEMIA, OR FACILITATE RETROGRADE BACTERIAL CONTAMINATION. IN THIS RETROSPECTIVE STUDY, THE AUTHORS INVESTIGATED THE SIGNIFICANCE OF PROPHYLACTIC DRAIN PLACEMENT AFTER LAPAROSCOPIC DISTAL GASTRECTOMY (LDG) FOR GASTRIC CANCER. THE STUDY CONSIST OF 78 PATIENTS (28 MALE AND 17 FEMALE; AGE RANGE: 57 TO 84 YEARS OLD) WITH GASTRIC CANCER WHO UNDERWENT LDG. THE PATIENTS WERE DIVIDED INTO 2 GROUPS ACCORDING TO THE INSERTION OF A PROPHYLACTIC INTRA-ABDOMINAL DRAIN FOLLOWING LDG. THE DRAIN GROUP (45 PATIENTS) WITH ROUTINE USE OF A PROPHYLACTIC INTRA-ABDOMINAL DRAIN AND THE NO-DRAIN GROUP (33 PATIENTS). IN THE DRAIN GROUP, A LOW-SUCTION J-VAC SILICON DRAIN AND BLAKE SILICON DRAIN KITS WAS PLACED IN THE FORAMEN OF WINSLOW VIA THE RIGHT UPPER QUADRANT INCISION. THE SILICON DRAIN HAS A SOLID-CORE STRUCTURE WITH A THREE-DIMENSIONAL CORE, WHICH ALLOWS THE LUMEN TO RETAIN ITS ROUND SHAPE, AND FOUR DRAINAGE CHANNELS INSIDE THE LUMEN. THE SUCTION BAG HAS AN INTERNAL SPRING STRUCTURE, WHICH PROVIDES CONSTANT AND SUSTAINABLE NEGATIVE PRESSURE. IT WAS REPORTED THAT COMPLICATIONS IN THE DRAIN GROUP INCLUDED ABSCESS IN 3 PATIENTS WHICH WAS TREATED WITH AN INTERVENTIONAL RADIOLOGY FOR ABSCESS DRAINAGE IN 1 PATIENT AND ANTIBIOTICS AND FASTING IN 2 PATIENTS, WOUND INFECTION IN 4 PATIENTS, ANASTOMOTIC EDEMA IN 3 PATIENTS, STASIS IN 4 PATIENTS, AND PULMONARY INFECTION IN 2 PATIENTS. IT WAS REPORTED THAT THE INTRA-ABDOMINAL ABSCESS AND SSI OCCURRED MORE FREQUENTLY IN THE DRAIN GROUP, SUGGESTING THAT RETROGRADE INFECTIONS THROUGH THE DRAIN OR DRAINAGE FAILURE IN CASES WITH PANCREATIC FISTULAS MAY BE INVOLVED IN SUCH INFECTIOUS COMPLICATIONS. IT WAS CONCLUDED THAT THE PROPHYLACTIC DRAIN MAY BE USEFUL IN PATIENTS AT HIGHER RISK AND IN THOSE WITH A LONGER OPERATIVE TIME OR MASSIVE INTRAOPERATIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150033 JVAC UNKNOWN PRODUCT CATHETER AND TIP SUCTION JOL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention