BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC INSTRUMENT COMPONENT

    MDR report key: 4202674 · Received August 19, 2014

    Report

    Report Number
    8043817-2014-00005
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ECOLAB MICROTEK DOMINICANA
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS ISSUE IS WORN OUT TOOLS FROM THE SUPPLIER, PARKER. PARKER IS A MATERIAL SUPPLIER FOR ECOLAB. PARKER HAS RECEIVED A SCAR FROM ECOLAB FOR CORRECTIVE ACTION. THE FOLLOWING ARE LIST ACTIONS REQUIRED TO IMPLEMENT: REFURBISH TOOLS; QUARANTINE AND RE-INSPECT THE PARTS IN FG AND WIP; RE-TRAIN THE OPERATORS AND ISSUE QUALITY ALERTS; INSTITUTE A POKA YOKE METHOD TO ASSURE ONLY ACCEPTABLE PARTS CAN BE SHIPPED.

    Description of Event or Problem · 1

    ECOLAB HEALTHCARE, MEDICAL DEVICE, BECAME AWARE OF THE INCIDENT REPORTED BY A STAFF FROM INTUITIVE SURGICAL INC. ON (B)(6) 2014. THE REPORTED CONCERNED A FLASH OF CANNULA SEALS FALLING INTO A PT'S ABDOMEN. THE INTENDED USE OF THE CANNULA SEAL IS TO PROVIDE A SEAL BETWEEN THE CANNULA HOUSING AND THE OBTURATOR USED DURING A SURGICAL PROCEDURE. THE FOLLOWING STATEMENT IS A COMPLAINT FROM THE HOSPITAL ABOUT THE INCIDENT AND WAS REPORTED TO INTUITIVE COMPANY. THE INCIDENT INVOLVED THE HOSPITAL STAFF FINDING A PIECE OF FLASH FROM THE CANNULA SEAL, PART # (B)(4), HAD FALLEN INTO THE PT'S ABDOMEN BUT THAT NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500159 ROBOTIC INSTRUMENT COMPONENT CANNULA SEALS NAY ECOLAB MICROTEK DOMINICANA 420291-03 D140995

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK