BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 17719681 · Received September 11, 2023

    Report

    Report Number
    1717344-2023-01116
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    November 25, 2022
    Report Date
    September 11, 2023
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: PREVIOUS NONHEPATECTOMY ABDOMINAL SURGERY DID NOT INCREASE THE DIFFICULTY IN LAPAROSCOPIC HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA: A CASE¿CONTROL STUDY IN 100 CONSECUTIVE PATIENTS. SOURCE: YI-HSUAN LEE, HSIU-HSIEN LIN, TSAI-LING KUO, MING-CHE LEE, YEN-CHENG CHEN / TZU CHI MEDICAL JOURNAL 2023; 35 (3): 247-252 / WEB PUBLICATION : 13-FEB-2023. 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, A RETROSPECTIVE STUDY AIMED TO EVALUATE THE OUTCOMES OF LAPAROSCOPIC HEPATECTOMY IN PATIENTS WITH HEPATOCELLULAR CARCINOMA AND WITH A HISTORY OF ABDOMINAL SURGERY BETWEEN (B)(6) 2013 AND (B)(6) 2021. A LIGASURE AND OTHER NON-MEDTRONIC DEVICES WERE USED FOR ADHESIOLYSIS AND PARENCHYMAL TRANSECTION. THERE WERE 100 PATIENTS IN THE STUDY WITH 23 WHO HAD PREVIOUS ABDOMINAL SURGERY AND 77 WHO DID NOT. TWO PATIENTS IN THE NON-PREVIOUS ABDOMINAL SURGERY GROUP EXPERIENCED MASSIVE AND UNCONTROLLABLE BLEEDING DURING PARENCHYMA TRANSECTION AND REQUIRED CONVERSION TO OPEN SURGERY. BLOOD TRANSFUSIONS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143894 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention