BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10777537 · Received November 3, 2020

    Report

    Report Number
    1717344-2020-01345
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 3, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: FLEXIBLE ENDOSCOPY ASSISTED BY LIGASURE¿ FOR TREATMENT OF ZENKER¿S DIVERTICULUM: AN EFECTIVE AND SAFE PROCEDURE SOURCE: SURGICAL ENDOSCOPY HTTPS://DOI.ORG/10.1007/S00464-020-08001-9. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY THAT PROSPECTIVELY ANALYZED 46 PATIENTS WHO UNDERWENT INCLUDED PATIENTS TREATED BY FLEXIBLE ENDOSCOPY USING LIGASURE FOR RESECTION OF ZENKER¿S DIVERTICULUM AT A SINGLE CENTER BETWEEN 2009 AND 2018 BY THREE ENDOSCOPISTS. AFTER REACHING INTENDED POSITION, THE LIGASURE BLADES WERE OPENED AND CLOSED, CATCHING THE SEPTUM. IT WAS COAGULATED, SEALED AND FINALLY CUT IN THE MIDDLE TO 3 MM FROM THE BOTTOM OF THE DIVERTICULUM. THIS PROCEDURE WAS REPEATED IF SOME MUSCLE FIBERS REMAINED UNCUT. THE DISSECTION WAS CONSIDERED COMPLETE WHEN MUSCLE LAYER FIBERS WERE OBSERVED. AT THE END OF THE PROCEDURE, ONE OR TWO ENDOCLIPS WERE PLACED AT THE BASE OF THE DISSECTION TO AND PREVENT MICROPERFORATION OR BLEEDING. THERE WAS ONE CASE OF SIGNIFICANT BLEEDING WHICH REQUIRED ENDOSCOPIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245301 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention