BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 15099256 · Received July 25, 2022

    Report

    Report Number
    1717344-2022-00901
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    March 17, 2022
    Report Date
    July 25, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: DO EARLY OUTCOMES OF SLEEVE GASTRECTOMY IMPROVE THE FIRST YEAR AFTER COMPLETING A BARIATRIC SURGERY FELLOWSHIP? SOURCE: BARIATRIC SURGICAL PRACTICE AND PATIENT CARE VOLUME 17, NUMBER 1, 2022, MARY ANN LIEBERT, INC. DOI: 10.1089/BARI.2020.0102. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE, A STUDY WAS PERFORMED BETWEEN 2013-2014 AND 2016-2017 TO COMPARE THE EARLY POSTOPERATIVE OUTCOME OF PATIENTS WHO UNDERWENT SLEEVE GASTRECTOMY AND WERE OPERATED ON BY A SINGLE SURGEON BEFORE AND AFTER COMPLETION OF BARIATRIC SURGERY FELLOWSHIP. THERE WERE 49 PATIENTS IN THE BEFORE TRAINING GROUP AND 117 PATIENTS IN THE AFTER TRAINING GROUP. TWO PATIENTS IN THE POST FELLOWSHIP HAD INTRAOPERATIVE COMPLICATIONS. ONE HAD AN INTRAOPERATIVE BLEED FROM A SHORT GASTRIC VESSEL. THE PATIENT LOST 1600 CC OF BLOOD AND REQUIRED TRANSFUSION OF TWO PACKED RED BLOOD CELLS. THE OTHER PATIENT HAD THE ORONASAL THERMOMETER CUT BY THE STAPLER. THE INCIDENT WAS RECOGNIZED ONLY WHEN THE ANESTHESIOLOGIST NOTIFIED THE SURGICAL TEAM. AN UPPER ENDOSCOPY WAS PERFORMED AND A 5 MM GAP AT THE STAPLED LINE WAS IDENTIFIED WHERE THE THERMOMETER WAS CUT. THIS WAS CLOSED WITH SUTURES AND A LEAK TEST CONFIRMATION. BOTH PATIENTS WERE DISCHARGED ON POSTOPERATIVE DAY 4. THERE WAS ONE PATIENT IN EACH GROUP WHO HAD A POSTOPERATIVE BLEEDING EVENT THAT REQUIRED BLOOD TRANSFUSION AND LAPAROSCOPIC EXPLORATION. THE PATIENT WHO BLED IN THE PRE-FELLOWSHIP GROUP RETURNED TO THE EMERGENCY DEPARTMENT 1 WEEK AFTER THE OPERATION WITH HYPOTENSION, ABDOMINAL PAIN, AND HEMOGLOBIN DROP. THE SOURCE OF BLEEDING COULD NOT BE IDENTIFIED AT EXPLORATION. AFTER BLOOD CLOT EVACUATION, HEMOSTATIC GLUE WAS SPRAYED ALONG THE STAPLE LINE. THE PATIENT WHO BLED IN THE POST-FELLOWSHIP GROUP HAD BLOOD IN THEIR DRAIN AND HEMOGLOBIN DROP. SHE WAS TAKEN BACK TO THE OPERATING ROOM ON POSTOPERATIVE DAY 2. THE SOURCE OF BLEEDING WAS FOUND AT THE UPPER STAPLE LINE. TWO PATIENTS FROM THE PRE-FELLOWSHIP GROUP RETURNED TO THE EMERGENCY ROOM WITH FEVER AND ABDOMINAL PAIN 10 AND 12 DAYS AFTER THE OPERATION. A COMPUTED TOMOGRAPHY SCAN DEMONSTRATED A FLUID COLLECTION WITH AIR BUBBLES NEXT TO THE SLEEVE. BOTH PATIENTS UNDERWENT CT-GUIDED DRAINAGE AND WERE TREATED WITH INTRAVENOUS ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706989 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN MFG DC BOULDER UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R