BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8581926 · Received May 6, 2019

    Report

    Report Number
    8581926
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 15, 2019
    Report Date
    April 17, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    UDI-DI
    00191072046260
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CARILION CUSTOM ROBOTIC DRAPE WITHIN THE PACK TEARS EASILY. ROBOTIC DRAPE SEAM CAME APART ON RIGHT SIDE AT THE TOP OF THE DRAPE AT THE PATIENT'S CHEST AND SPLIT DOWN THE SIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376908 ACS GENERAL SURGERY STERILE SUPPLY PACK LRO AMERICAN CONTRACT SYSTEMS, INC. CDRO64F 667181 00191072046260

    Patients

    Seq Age Sex Outcome Treatment
    1