BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 10713577 · Received October 21, 2020

    Report

    Report Number
    1219930-2020-04353
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    August 9, 2020
    Report Date
    October 21, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: POWERED ARTICULATION BY SIGNIA STAPLING SYSTEM FOR STAPLING POSITION ADJUSTMENTS: OPTIMIZING SAFE SURGICAL MARGINS IN THORACOSCOPIC SUBLOBAR RESECTION. SOURCE: SURGERY TODAY. HTTPS://DOI.ORG/10.1007/S00595-020-02109-0 ONLINE PUBLICATION 09 AUGUST 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, IN A LITERATURE ARTICLE INTRODUCING THE USAGE OF THE SIGNIA STAPLING SYSTEM FOR OBTAINING SAFE SURGICAL MARGINS IN VIDEO ASSISTED THORACIC SURGERY. POSTOPERATIVE ADVERSE EVENTS REPORTED IN THE GROUP: PROLONGED AIR LEAKAGE (3), ARRHYTHMIA (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180247 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention