BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUST RIGHT VESSEL SEALING SYSTEM

    MDR report key: 13019057 · Received December 15, 2021

    Report

    Report Number
    MW5106084
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 13, 2021
    Manufacturer
    JUST RIGHT SURGICAL / BOLDER SURGICAL, LLC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS TAKEN TO SURGERY TO REPAIR A CONGENITAL PULMONARY AIRWAY MALFUNCTION. THE PROCEDURE WENT WELL, BUT WHEN THE PATIENT WAS IN THE PACU, HE HAD A CARDIAC AND PULMONARY ARREST REQUIRING CPR. THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND WHEN VISUALIZED THE ENTIRE BRONCHIAL STAPLE LINE WAS DISRUPTED. THE CAUSE IS NOT KNOWN. THE SURGEON REPAIRED THE BRONCHIAL STAPLE LINE. THE PATIENT SURVIVED AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS EXAMINED BY NEUROLOGY. AN MRI WAS DONE AND THE PATIENT HAS HAD SEIZURES REQUIRING NEW MEDICATIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913160 JUST RIGHT VESSEL SEALING SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI JUST RIGHT SURGICAL / BOLDER SURGICAL, LLC. 5 MM STAPLER AND VESSEL SEALING

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Male Life Threatening| H