BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 16205065 · Received January 19, 2023

    Report

    Report Number
    1219930-2023-00255
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    February 6, 2022
    Report Date
    January 19, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ENDO GIA INSTRUMENT (LOT#UNKNOWN); UNKNOWN LIGASURE INSTRUMENT (LOT#UNKNOWN); UNKNOWN LIGASURE INSTRUMENT(LOT#UNKNOWN); TITLE: ANALYSIS OF SURGICAL APPROACH AND TUMOR DISTANCE TO MARGIN AFTER LIVER RESECTION FOR COLORECTAL LIVER METASTASIS ARTICLE: JOURNAL OF ROBOTIC SURGERY (2022) 16:1427¿1439 HTTPS://DOI.ORG/10.1007/S11701-022-01387-9 RECEIVED: 22 NOVEMBER 2021 / ACCEPTED: 6 FEBRUARY 2022 / PUBLISHED ONLINE: 24 FEBRUARY 2022 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2016 TO 2021 REGARDING A STUDY TO COMPARE TUMOR DISTANCE TO MARGIN ON 56 PATIENTS AFTER ROBOTIC VS. OPEN HEPATECTOMY FOR COLORECTAL LIVER METASTASES (CLM) AND TO DETERMINE THE RELATIONSHIP BETWEEN PERIOPERATIVE VARIABLES, SURGICAL APPROACH AND TUMOR DISTANCE TO MARGIN WITH OVERALL SURVIVAL PARENCHYMAL. PATIENTS WERE RANDOMIZED IN 2 GROUPS, WITH 42 PATIENTS FOR ROBOTIC AND 14 PATIENTS FOR OPEN PROCEDURE. THE ASSISTANT USED SEALER TO ACHIEVE HEMOSTASIS FROM THE LIVER SURFACE AS THE PARENCHYMAL TRANSECTION WAS BEING CARRIED OUT. SMALL CROSSING VESSELS LESS THAN 7 MM WERE DIVIDED WITH SEALING DEVICE, WHILE LARGE CROSSING VESSELS MORE THAN 7 MM WERE HANDLED WITH 3¿0 SILK SEALING DEVICE OR VASCULAR STAPLERS. THERE WAS BLEEDING COMPLICATION AND ESTIMATED BLOOD LOSS WAS 200 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101855 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female UNKNOWN ENDO GIA INSTRUMENT (LOT#UNKNOWN)