BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 7970354 · Received October 16, 2018

    Report

    Report Number
    2951238-2018-00622
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 26, 2018
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170239113
    PMA / PMN Number
    K063786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. IN ADDITION, INSUFFICIENT INFORMATION REGARDING THE REPORTED DEVICE, PATIENT AND PROCEDURE WAS REPORTED. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY. HOWEVER, BASED ON THE REPORTED INFORMATION THE OPERATOR¿S TECHNIQUE CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE OLYMPUS SALES REPRESENTATIVE REPORTED THAT THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD BE ATTRIBUTED TO BOTH THE UCR AND CLV-190 AIR SUPPLY BEING ON AT THE SAME TIME. THE INSTRUCTION MANUAL FOR THE UCR WARNS, ¿DURING USE, ALWAYS STOP THE DEVICE LIKE LIGHT SOURCE FROM SUPPLYING AIR. IF STOP IS NOT SELECTED, A MIXTURE OF AIR AND CO2 MAY BE SUPPLIED INTO THE PATIENT BODY.¿ IN ADDITION, THE INSTRUCTION MANUAL FOR THE CLV-190 (SECTION 5.9) ALSO PROVIDES WARNING THAT STATES, ¿OVER-INSUFFLATING THE LUMEN MAY CAUSE PATIENT PAIN, INJURY, BLEEDING, GAS EMBOLISM, AND/OR PERFORATION.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A PNEUMOPERITONEUM PROCEDURE, THE PATIENT¿S CECUM WAS PERFORATED. THE PATIENT WAS GIVEN VERSED AND SENTINOL FOR SEDATION AND THE PROCEDURE LASTED 30 MINUTES. THE AIR FROM THE LIGHT SOURCE (CLV-190) AND CO2 FROM THE REGULATION UNIT (UCR) WERE USED SIMULTANEOUSLY DURING THE PROCEDURE AS THE PHYSICIAN SWITCHED BACK AND FORTH BETWEEN AIR AND CO2. THE PHYSICIAN NOTED THAT BOTH THE AIR AND CO2 WERE ON AT THE SAME TIME. A FEW HOURS AFTER THE PROCEDURE WAS COMPLETED, WHILE THE PATIENT WAS IN RECOVERY, THE PATIENT EXPERIENCED ABDOMINAL PAIN. IT WAS DETERMINED THAT THE PATIENT NEEDED A SURGICAL PROCEDURE TO TREAT A CECAL PERFORATION. 1 OF 2 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810949 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UCR 04953170239113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COLONOSCOPE: OLYMPUS CF-HQ190L, SERIAL UNKNOWN| LIGHT SOURCE: OLYMPUS CLV-190, SERIAL: UNKNOWN| TUBING FOR UCR: MEDIVATOR MODEL/SERIAL UNKNOWN| COLONOSCOPE: OLYMPUS CF-HQ190L, SERIAL UNKNOWN| LIGHT SOURCE: OLYMPUS CLV-190, SERIAL: UNKNOWN| TUBING FOR UCR: MEDIVATOR MODEL/SERIAL UNKNOWN