BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 17547406 · Received August 14, 2023

    Report

    Report Number
    1717344-2023-00998
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 14, 2023
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE EVENTS: WEIPENG HU1, PEISONG YUAN1, YONG YUAN1, LONGQI CHEN1, YANG HU1 LEARNING CURVE FOR INFLATABLE MEDIASTINOSCOPIC AND LAPAROSCOPIC-ASSISTED ESOPHAGECTOMY, WEIPENG HU, 18 JANUARY 2023, SURGICAL ENDOSCOPY (2023) SURGICAL ENDOSCOPY (2023) 37:4486¿4494. HTTPS://DOI.ORG/10.1007/S00464-023-09903-0. RECEIVED: 23 OCTOBER 2022 / ACCEPTED: 18 JANUARY 2023 / PUBLISHED ONLINE: 21 FEBRUARY 2023 © THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 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

    PLI10: ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY BETWEEN JULY 2018 AND NOVEMBER 2020, IDENTIFIED THE MORBIDITY ASSOCIATED WITH THE LEARNING CURVE IN PATIENTS WITH ESOPHAGEAL CANCER WHO UNDERWENT INFLATABLE MEDIASTINOSCOPIC AND LAPAROSCOPIC-ASSISTED ESOPHAGECTOMY. LIGASURE WAS USED TO PERFORM EN-BLOCK DISSECTION OF THE ESOPHAGUS, SURROUNDING TISSUES AND LYMPH NODES FROM THORACIC INLET TO THE LEVEL OF UPPER TRACHEA. THERE WERE 108 PATIENTS IN THE STUDY AND ONE PATIENT DEVELOPED POSTOPERATIVE CHYLOTHORAX AND REQUIRED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665442 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention