BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 8236817 · Received January 10, 2019

    Report

    Report Number
    1717344-2019-00066
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    June 11, 2009
    Report Date
    January 10, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE LAPAROSCOPIC RECTAL SURGERY FOR MIDDLE AND LOWER RECTAL CANCER. SOURCE SURG ENDOSC. (145-151), 2010. ARTICLE NUMBER: 24 DATE OF PUBLICATION: 01 OCT 2008. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI-10: ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED ON 1998, THE LITERATURE ARTICLE WAS RELATED TO A RETROSPECTIVE ASSESSMENT ON 98 PATIENTS THAT UNDERWENT LAPAROSCOPIC MIDDLE AND LOWER RECTAL SURGERY FOR CANCER. 5 OUT OF THE 98 HAD A CONVERSION TO OPEN AND 6 PATIENT EXPERIENCED WOUND INFECTIONS. PLI-20: ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED ON 1998, THE LITERATURE ARTICLE WAS RELATED TO A RETROSPECTIVE ASSESSMENT ON 98 PATIENTS THAT UNDERWENT LAPAROSCOPIC MIDDLE AND LOWER RECTAL SURGERY FOR CANCER. 13 CASES OF ANASTANOMOTIC LEAKAGE WAS REPORTED AND 4 PATIENT SUFFERED FROM ANASTOMOTIC BLEED. ARTICLE: LAPAROSCOPIC RECTAL SURGERY FOR MIDDLE AND LOWER RECTAL CANCER; AUTHOR: YOSUKE FUKUNAGA, YEAR: 2009, PUBLICATION: SPRINGER SCIENCE+BUSINESS MEDIA, LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28269 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other