BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 15458324 · Received September 20, 2022

    Report

    Report Number
    1717344-2022-01148
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    February 7, 2022
    Report Date
    September 20, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE: TITLE: IS THE ANTERIOR APPROACH SUITABLE FOR LAPAROSCOPIC RIGHT HEMIHEPATECTOMY IN PATIENTS WITH LARGE HCC (5¿10 CM)? A PROPENSITY SCORE ANALYSIS. SOURCE: SURGICAL ENDOSCOPY (2022) 36:6024¿6034 HTTPS://DOI.ORG/10.1007/S00464-022-09119-8 ACCEPTED DATE: (B)(6) 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 FROM JANUARY 2015 AND AUGUST 2018 COMPARED OUTCOMES BETWEEN LAPAROSCOPIC RIGHT HEMIHEPECTOMY AND OPEN RIGHT HEMIHEPATECTOMY VIA THE ANTERIOR APPROACH. IN THE LAPAROSCOPIC GROUP, LIGASURE OR ANOTHER DEVICE WAS USED FOR DEEP PARENCHYMAL DISSECTION. IN ADDITION, OTHER COMPETITOR DEVICES WERE USED FOR TRANSECTION AND SUPERFICIAL PARENCHYMAL DISSECTION. LIGASURE WAS NOT USED IN THE OPEN GROUP. THERE WERE 40 PATIENTS IN THE LAPAROSCOPIC GROUP AND COMPLICATIONS INCLUDED BLEEDING AND HEMORRHAGE. ONE PATIENT REQUIRED CONVERSION TO OPEN PROCEDURE DUE TO UNCONTROLLED HEMORRHAGE FOLLOWING INJURY TO THE MIDDLE HEPATIC VEIN. ONE PATIENT IN THE LAPAROSCOPIC GROUP EXPERIENCED POSTOPERATIVE HEMORRHAGE AND REQUIRED BLOOD TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484209 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention