BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRI STAPLE PRODUCT

    MDR report key: 9695094 · Received February 11, 2020

    Report

    Report Number
    1219930-2020-00670
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    February 2, 2018
    Report Date
    February 11, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ROBOTIC VERSUS LAPAROSCOPIC DISTAL PANCREATECTOMY: A FRENCH PROSPECTIVE SINGLE-CENTER EXPERIENCE AND COST-EFFECTIVENESS ANALYSIS SOURCE: SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2018, RECEIVED: 15 SEPTEMBER 2017; ACCEPTED: 28 JANUARY 2018; PUBLISHED ONLINE 02 FEBRUARY 2018. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE STUDY, THIS IS TO COMPARE THE SHORT-TERM RESULTS OF THE DEVICE IN ROBOTIC DISTAL PANCREATECTOMY AND LAPAROSCOPIC DISTAL PANCREATECTOMY FROM 2011 UNTIL 2016. THE DISTAL PANCREATECTOMY WAS PERFORMED TO 38 PATIENTS, AGES 44-83 YEARS OLD WITH 12 MALES AND 26 FEMALES. IN ROBOTIC DISTAL PANCREATECTOMY, THERE WERE FIVE PATIENTS HAD POSTOPERATIVE COMPLICATIONS. SIX PATIENTS HAD PANCREATIC FISTULA. ONE PATIENT HAD PULMONARY COMPLICATIONS. ONE PATIENT WAS RE-OPERATED WITHIN 90 DAYS. HOWEVER, IN LAPAROSCOPIC DISTAL PANCREATECTOMY, THERE WERE 11 PATIENTS HAD POSTOPERATIVE COMPLICATIONS. 10 PATIENTS HAD PANCREATIC FISTULA. THREE PATIENT HAD PULMONARY COMPLICATIONS. TWO PATIENT WAS READMITTED WITHIN 90 DAYS DUE TO FEVER WITH PERIPANCREATIC FLUID COLLECTION TREATED SUCCESSFULLY BY ANTIBIOTICS. ONE PATIENT WAS RE-OPERATED WITHIN 90 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159114 UNKNOWN TRI STAPLE PRODUCT STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN TRI STAPLE PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention