BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC ROBOTIC CDS

    MDR report key: 7665956 · Received July 6, 2018

    Report

    Report Number
    7665956
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 19, 2018
    Report Date
    June 29, 2018
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    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

    BREAK IN ASEPTIC TECHNIQUE DURING SURGICAL PROCEDURE. DURING CASE RESIDENT ASSISTING MOVED OVER TO THE ROBOTIC CONSOLE AND SCRUBBED MOVED UP TO START ASSISTING. AT THAT TIME IT WAS NOTICED THAT THE DRAPE HAD RIPPED ON THE LEFT SIDE OF THE PATIENT. NOT SURE HOW LONG IT HAD BEEN RIPPED BUT IT WAS DOWN TO THE BAIR HUGGER. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. SCRUB FIXED BY PUTTING STERILE GREEN TOWEL OVER THE RIP IT WAS VERY LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508620 CMC ROBOTIC CDS PACKS, MULTIPLE LRO AMERICAN CONTRACT SYSTEMS 893181

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA