BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 15421291 · Received September 14, 2022

    Report

    Report Number
    1717344-2022-01123
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    February 12, 2022
    Report Date
    September 14, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: THORACOSCOPIC RESYMPATHECTOMY FOR PERSISTENT OR RECURRENT PALMAR HYPERHIDROSIS: SINGLE-CENTER EXPERIENCE SOURCE: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2022) 70:651¿658, ACCEPTED DATE: 12 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, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT THORACOSCOPIC RESYMPATHECTOMY FOR PERSISTENT OR RECURRENCE PALMAR HYPERHIDROSIS BETWEEN 2005 AND 2020. LIGASURE MARYLAND JAW OPEN AND LAPAROSCOPIC SEALER/DIVIDER WAS USED TO TRANSECT THE SYMPATHETIC CHAIN. THERE WERE 39 PATIENTS IN THE STUDY AND A REOPERATION OR A CHEST TUBE POSITIONING WAS NECESSARY IN 2 PATIENTS DUE TO A POSTOPERATIVE HEMOTHORAX, OCCURRED 12 HOURS AFTER SURGERY, AND A WORSENING PNEUMOTHORAX AT THE SECOND POSTOPERATIVE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2740867 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention UNKNOWN LIGASURE (LOT NUMBER: UNKNOWN)