BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 7867166 · Received September 11, 2018

    Report

    Report Number
    2951238-2018-00532
    Event Type
    Death
    Date Received
    September 11, 2018
    Date of Event
    December 23, 2015
    Report Date
    September 11, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170237294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE DID NOT PROVIDE THE SPECIFIC MODELS OR SERIAL NUMBERS OF THE COLONOSCOPIES USED DURING THE PROCEDURES; THEREFORE, IT IS UNKNOWN IF EITHER OF THE SCOPES WERE RETURNED TO OLYMPUS FOR REPAIR/SERVICE. IN ADDITION, OLYMPUS IS UNABLE TO PERFORM A REVIEW OF THE INSTRUMENT¿S HISTORY. THIS REPORT IS BEING FILED IN ABUNDANCE OF CAUTION. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED AN ARTICLE TITLED ¿HOW A PUSH TO CUT COSTS AND BOOST PROFITS AT SURGERY CENTERS LED TO A TRAIL OF DEATH." THE ARTICLE MENTIONS THAT TWO PATIENT EXPIRED AFTER UNDERGOING PROCEDURES AT TWO DIFFERENT FACILITIES. ACCORDING TO THE ARTICLE, THE FIRST PATIENT STOP BREATHING DURING A SCREENING COLONOSCOPY PROCEDURE AT OAK TREE SURGERY CENTER IN EDISON, NEW JERSEY. DUE TO THE CENTER NOT HAVING THE APPROPRIATE SIZE AIRWAY TUBE AVAILABLE, THE PATIENT WAS NOT INTUBATED UNTIL THE PARAMEDICS ARRIVED 33 MINUTES LATER. THE PATIENT WAS REMOVED FROM LIFE SUPPORT TWO DAYS AFTER THE PROCEDURE. A COPY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES REPORT WAS INCLUDED IN THE ARTICLE AND STATES ¿IT WAS DETERMINED THAT THE FACILITY FAILED TO ENSURE A SAFE ENVIRONMENT IS MAINTAINED TO PROTECT THE HEALTH AND SAFETY OF PATIENTS. IT WAS ALSO DETERMINED THAT THE FACILITY FAILED TO ENSURE EMERGENCY MEDICAL EQUIPMENT WAS READILY AVAILABLE TO HANDLE EMERGENCIES.¿ THE SECOND PATIENT WAS DISCOVERED UNRESPONSIVE 10 MINUTES AFTER UNDERGOING AN UPPER DIGESTIVE TRACT PROCEDURE WITH A SCOPE AT AMBULATORY CARE CENTER IN NEW JERSEY. ACCORDING TO THE AUTHOR, THE PATIENT¿S WIDOW REPORTED AN EXTENDED DELAY WITH THE CENTER¿S INTERVENTION AND AS A RESULT THE PATIENT NEVER REGAINED CONSCIOUSNESS. THERE WAS NO ADMISSION OF WRONG DOING BY THE CENTER¿S STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708111 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN 04953170237294

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R