BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORCE GSU-22

    MDR report key: 11633424 · Received April 8, 2021

    Report

    Report Number
    1717344-2021-00535
    Event Type
    Death
    Date Received
    April 8, 2021
    Date of Event
    December 5, 2016
    Report Date
    April 8, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ABANDONING PROPHYLACTIC ABDOMINAL DRAINAGE AFTER HEPATIC SURGERY: 10 YEARS OF NO-DRAIN POLICY IN AN ENHANCED RECOVERY AFTER SURGERY ENVIRONMENT SOURCE: DIG SURG 2017;34:411¿420. 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 PERFORMED BETWEEN 2005¿2014, ROUTINE PROPHYLACTIC ABDOMINAL DRAINAGE AFTER HEPATIC SURGERY IS STILL BEING DEBATED, AS IT MAY BE UNNECESSARY, POSSIBLY HARMFUL, AND UNCOMFORTABLE FOR PATIENTS. THE AIM OF THIS STUDY WAS TO EXAMINE THE POSTOPERATIVE COMPLICATION AND REINTERVENTION RATES IN PATIENTS UNDERGOING LIVER RESECTION THAT WERE TREATED WITHOUT PROPHYLACTIC DRAINS IN AN ERAS (ENHANCED RECOVERY AFTER SURGERY)ENVIRONMENT. ALL HEPATECTOMIES PERFORMED WITHOUT PROPHYLACTIC DRAINAGE WERE INCLUDED. MORTALITY WITHIN 90 DAYS AFTER SURGERY WAS OBSERVED IN 15 PATIENTS (2.8%). WITHIN THIS GROUP, 5 PATIENTS DIED FROM SEPSIS FOLLOWING AN INTRA-ABDOMINAL ABSCESS OR BILOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536459 FORCE GSU-22 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FORCEGSU-22

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death