BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-VLOCESAB

    MDR report key: 8420258 · Received March 14, 2019

    Report

    Report Number
    1219930-2019-01515
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    April 23, 2014
    Report Date
    March 14, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS SOURCE DIGESTIVE SURGICAL, 2014 (95-103) DATE OF PUBLICATION: 23 APRIL 2014. 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 FROM JANUARY 2011 UNTIL AUGUST 2012, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. EIGHTEEN OUT OF THE 45 PATIENTS WERE UNDER GROUP 2 WHEREIN A CIRCULAR STAPLER WAS USED TO CREATE AN INTRATHORACIC ANASTOMOSIS ALONG WITH ITS ANVIL BEING INSERTED THROUGH ONE OF THE PORTS AND SECURED WITH 2 PURSE STRINGS USING THE STITCHING DEVICE AND SUTURE. EIGHT PATIENTS DEVELOPED PULMONARY COMPLICATIONS AND 5 PATIENTS DEVELOPED CARDIAC COMPLICATIONS. THREE PATIENTS WERE RE-OPERATED, FOUR PATIENTS WERE RE-ADMITTED TO THE ICU AND THREE WERE RE-ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213727 UNK-VLOCESAB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNK-VLOCESAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R