BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 5858146 · Received August 9, 2016

    Report

    Report Number
    2951238-2016-00676
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    June 22, 2016
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    PK081173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. OLYMPUS MADE MULTIPLE FOLLOW UPS BY TELEPHONE AND IN WRITING IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FCX TO HIF.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE PATIENT'S COLON WAS PERFORATED DURING A COLONOSCOPY PROCEDURE. AN OLYMPUS ENDOSCOPE (MODEL AND SERIAL NUMBER UNKNOWN) WAS ALSO USED IN THE PROCEDURE. IT WAS ALSO REPORTED THAT THE FACILITY WAS USING NON OLYMPUS TUBING, NON OLYMPUS VALVES, AND NON OLYMPUS WATER BOTTLE WITH THE REPORTED UCR MACHINE. THE PATIENT'S OUTCOME IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510305 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UCR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other