BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CURVED STERNAL RETRACTOR

    MDR report key: 5338057 · Received December 29, 2015

    Report

    Report Number
    1723241-2015-00001
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    October 21, 2015
    Report Date
    December 23, 2015
    Manufacturer
    GENESEE BIOMEDICAL, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DEFIBRILLATION SUBSEQUENT TO MITRAL VALVE REPAIR AND CORONARY BYPASS GRAFTING, ONE OF THE BEARINGS HOLDING THE BLADES OF THE STERNAL RETRACTOR FAILED AND THE CHEST INCISION CLOSED ABRUPTLY. THE ANESTHETIST PERFORMED TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY AND DETERMINED THAT THE AORTA WAS DISSECTED AND THE LIMA GRAFT WAS DETACHED. THE CARDIAC SURGEON RETURNED TO THE OPERATING ROOM AND PERFORMED SURGERY TO REPAIR THE AORTA AND REGRAFTED THE LIMA. THE REPAIR WAS SUCCESSFUL. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT HAS SINCE PASSED AWAY, AND A CORONER'S INVESTIGATION IS IN PROCESS TO ASSESS IF THE INCIDENT WAS RELATED TO HIS DEATH. THE RETRACTOR WAS REMOVED AND INSPECTED. IT WAS DETERMINED THAT THE BEARING ON THIS RETRACTOR BLADE HAD FAILED. IT WAS NOTED THAT THE BEARING ON THE BLADE APPEARED TO BE CORRODED. THE RETRACTOR IS OVER 10 YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856826 ADULT CURVED STERNAL RETRACTOR CURVED STERNAL RETRACTOR GAD GENESEE BIOMEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R