BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRICKER SAGITTAL SAW

    MDR report key: 17908 · Received September 9, 1994

    Report

    Report Number
    17908
    Event Type
    Death
    Date Received
    September 9, 1994
    Date of Event
    August 26, 1994
    Report Date
    September 9, 1994
    Manufacturer
    STRYKER CORP.
    Product Code
    DWH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN SURGERY FOR HIS SECOND (?) OPEN HEART PROCEDURE (THE FIRST SURGERY WAS DONE IN 1983). THE OPERATIVE REPORT STATES THIS AS HIS THIRD OPEN HEART PROCEDURE. WHILE ATTEMPTING TO SEPARATE THE STERNUM WITH THE OSCILLATING SAW, A PORTION OF THE RIGHT VENTRICLE HAD DEHISCED (ALMOST THE ENTIRE LENGTH ANTERIORLY). THE HEART HAD BEEN INCREDIBLY SUCKED IN AND ADHERENT. THE DEHISCENCE WAS REPAIRED, AND CORONARY ARTERY BYPASS GRAFT X 3 WAS PERFORMED. THE PT EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRICKER SAGITTAL SAW SAGITTAL SAW DWH STRYKER CORP. 298-98

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death