BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8581890 · Received May 6, 2019

    Report

    Report Number
    8581890
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 17, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MAINTENANCE OF STERILITY ISSUE. THE CARILION CUSTOM ROBOTIC DRAPE WITHIN THE PACK TEARS EASILY. ROBOTIC DRAPE SEAMS SEPARATED DURING PROCEDURE. IT WAS ABOUT 14 INCH SEPARATION. UNSTERILE AREA OF DRAPE WAS COVERED WITH IOBAN AND THE SURGERY CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376217 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDRO64F 982191

    Patients

    Seq Age Sex Outcome Treatment
    1