BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 20762910 · Received November 22, 2024

    Report

    Report Number
    3002808148-2024-11124
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    September 5, 2024
    Report Date
    February 20, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    UDI-DI
    04953170239113
    PMA / PMN Number
    K081173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304 - 2024 - 0000466. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION TO G3 DATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER: 2429304-2024-0000466. A3A: MALE WAS INADVERTENTLY SELECTED AND COULD NOT UNSELECTED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ONE UNIT OF UCR (ENDOSCOPIC CO2 REGULATION UNIT) WAS RETURNED TO OLYMPUS AND THE INSPECTION WAS CONDUCTED. AS A RESULT, NO ABNORMALITY OF THE DEVICE WAS RECOGNIZED AND THE PHENOMENON WAS NOT REPRODUCED PER THE RETURNED UNIT. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS SPECIFIC DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED FOR THIS COMPLAINT. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE INFORMATION RECEIVED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SCREENING COLONOSCOPY, WHEN ANGULATING THE SCOPE, IT WOULD LOCK. THE PHYSICIAN WAS THUS UNABLE TO DISENGAGE DURING REMOVAL OF A POLYP, CAUSING THE COLON TO TEAR/PERFORATE. IT IS UNCLEAR IF THIS PATIENT UNDERWENT ANY TREATMENT. THE PHYSICIAN STATED THAT THE COLON WAS NOT INSUFFLATING DURING THE PROCEDURE, AND IT WAS UNCLEAR IF THE INSUFFLATOR MALFUNCTIONED OR IF THERE WAS A PROBLEM WITH THE SCOPE, OR IF IT WAS SOMETHING ELSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PENDING INFORMATION. THE CUSTOMER INDICATED 6 CASES OF PERFORATIONS OCCURRED. THUS, ADDITIONAL 4 CASES ARE REPORTED FOR PERFORATION. 2 PATIENTS HAD MICROPERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605365 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UCR 04953170239113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other COLONOVIDEOSCOPE, CF-H180AL, SN- (B)(6).