BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 14221874 · Received April 27, 2022

    Report

    Report Number
    1717344-2022-00502
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    March 8, 2020
    Report Date
    April 27, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: TRANSITION FROM OPEN AND LAPAROSCOPIC TO ROBOTIC PANCREATIC ODUODENECTOMY IN A (B)(6) TERTIARY REFERRAL HEPATOBILIARY AND PANCREATIC CENTRE EARLY EXPERIENCE OF ROBOTIC PANCREATIC ODUODENECTOMY SOURCE: HPB 2020, 22, 1637¿1644 ACCEPTED (B)(6) 2020. 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 COMPARED THE SHORT TERM OUTCOMES OF ROBOTIC PANCREATICODUODENECTOMY (RPD) WITH LAPAROSCOPIC PANCREATIC ODUODENECTOMY (LPD) AND OPEN PANCREATIC ODUODENECTOMY (OPD) OVER 66 MONTHS. OVER A 22-MONTH PERIOD FROM (B)(6) 2017, A TOTAL OF 25 RPD WERE PERFORMED. THIS WAS COMPARED TO A 22-MONTH PERIOD OF CONSECUTIVE LPD CASES FOLLOWING THE INTRODUCTION OF LPD IN (B)(6) 2011, AND CONSECUTIVE OPD OVER A 22-MONTH PERIOD PRIOR TO THE INTRODUCTION OF LPD BY THE SAME SURGEON. FOR THE LAPAROSCOPIC APPROACH, IT IS NOTED THAT A LIGASURE WAS USED FOR VESSEL SEALING AND AN ENDOGIA WAS USED FOR JEJUNAL RESECTION, GASTRO-JEJUNOSTOMY RECONSTRUCTION AND JEJUNO-JEJUNOSTOMY RECONSTRUCTION. THERE WERE 103 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED: BLEEDING REQUIRING BLOOD TRANSFUSION AND GASTRO-JEJUNOSTOMY LEAK RESULTING IN RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492803 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention