BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 9527265 · Received December 27, 2019

    Report

    Report Number
    1219930-2019-07208
    Event Type
    Death
    Date Received
    December 27, 2019
    Date of Event
    October 1, 2018
    Report Date
    December 27, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE COMPARISON OF INTRACORPOREAL AND EXTRACORPOREAL URINARY DIVERSIONS AFTER LAPAROSCOPIC RADICAL CYSTECTOMY IN FEMALES WITH BLADDER CANCER SOURCE WORLD JOURNAL OF SURGICAL ONCOLOGY 2019 (17:161) DATE OF ONLINE PUBLICATION: 12 SEPTEMBER 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED FROM FEBRUARY 2008 TO OCTOBER 2018, THE ARTICLE COMPARES THE PERI-OPERATIVE OUTCOMES OF FEMALES UNDERGOING LAPAROSCOPIC INTRACORPOREAL URINARY DIVERSIONS (ICUD) AND EXTRACORPOREAL URINARY DIVERSIONS (ECUD) AFTER LAPAROSCOPIC RADICAL CYSTECTOMIES (LRC). INCLUDED IN THIS STUDY ARE 19 PATIENTS IN BOTH THE ECUD GROUP AND THE ICUD GROUP FOR A TOTAL OF 38 PATIENTS. SEVEN PATIENTS HAD DISEASE METASTASES (ECUD 2 OUT OF 19, ICUD 5 OUT OF 19; P = 0.405) AND 5 DIED AFTER FOLLOWUP (ECUD 3 OUT OF 19, ICUD 2 OUT OF 19). INTRAPROCEDURE, THE DORSAL VEIN COMPLEX (DVC) WAS LIGATED WITH 2-0 V-LOC SUTURES TO AVOID USING INSTRUMENTS THAT CAUSED HEAT DAMAGE. POST PROCEDURE, 1 PATIENT (5%) HAD A CLAVIEN GRADE V COMPLICATION WHO LATER DIED DUE TO MULTIPLE ORGAN FAILURE RESULTING FROM A MYOCARDIAL INFARCTION WITHIN 30 DAYS. WU ET AL. WORLD JOURNAL OF SURGICAL ONCOLOGY (2019): LIYUAN WU1, FEIYA YANG1*, LIMING SONG2, ZEJUN XIAO1, SUJUN HAN1, SONG WU3, SAI LIU2, QINGBAO HE2 AND NIANZENG XING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319813 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death