BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10974878 · Received December 9, 2020

    Report

    Report Number
    1717344-2020-01484
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    December 13, 2019
    Report Date
    December 9, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: DOES TUMOR SIZE INFLUENCE THE OUTCOME OF LAPAROSCOPIC DISTAL PANCREATECTOMY? SOURCE: © 2019 INTERNATIONAL HEPATO-PANCREATO-BILIARY ASSOCIATION INC. PUBLISHED BY ELSEVIER LTD. HPB 2020, 22, 1280¿1287 ACCEPTED: 24 NOVEMBER 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY COLLECTED PATIENT DATABASE EVALUATED THE INFLUENCE OF TUMOR SIZE ON THE SURGICAL OUTCOMES OF PATIENTS UNDERGOING LAPAROSCOPIC DISTAL PANCREATECTOMY BETWEEN APRIL 1997 AND FEBRUARY 2017. IT WAS NOTED THAT A LIGASURE WAS THE MAIN DISSECTION INSTRUMENT. THERE WERE 422 PATIENTS INCLUDED IN THE STUDY AND POST-OPERATIVE COMPLICATIONS INCLUDED: SEVERE BLOOD LOSS (35), IATROGENIC INJURY OF ADJACENT ORGANS AND STRUCTURES (6) AND PNEUMOTHORAX (1). IT WAS NOTED THAT CONVERSION TO LAPAROTOMY WAS REQUIRED IN 9 OF THESE PATIENTS. DOES TUMOR SIZE INFLUENCE THE OUTCOME OF LAPAROSCOPIC DISTAL PANCREATECTOMY? AIRAZAT M. KAZARYAN, 24 NOVEMBER 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445972 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention