BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 14231663 · Received April 28, 2022

    Report

    Report Number
    1219930-2022-01530
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    March 8, 2020
    Report Date
    April 27, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    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 PANCREATICODUODENECTOMY IN A UK TERTIARY REFERRAL HEPATOBILIARY AND PANCREATIC CENTRE - EARLY EXPERIENCE OF ROBOTIC PANCREATICODUODENECTOMY SOURCE: HPB 2020, 22, 1637¿1644 ACCEPTED 8 MARCH 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY, A RETROSPECTIVE STUDY COMPARED THE SHORT TERM OUTCOMES OF ROBOTIC PANCREATICODUODENECTOMY (RPD) WITH LAPAROSCOPIC PANCREATICODUODENECTOMY (LPD) AND OPEN PANCREATICODUODENECTOMY (OPD) OVER 66 MONTHS. OVER A 22-MONTH PERIOD FROM MAY 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 APRIL 2011, AND CONSECUTIVE OPD OVER A 22-MONTH PERIOD PRIOR TO THE INTRODUCTION OF LPD BY THE SAME SURGEON. IT IS NOTED THAT A MANUAL STAPLER WAS USED FOR GASTRIC AND JEJUNAL TRANSECTION AND IN THE CREATION OF A GASTRO-JEJUNOSTOMY (GJ) IN THE ROBOTIC PROCEDURES. FOR THE LAPAROSCOPIC APPROACH, A MANUAL STAPLER 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, WOUND DEHISCENCE, GASTRO-JEJUNOSTOMY LEAK RESULTING IN RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689613 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention