BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 20364315 · Received October 3, 2024

    Report

    Report Number
    3002808148-2024-09588
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 5, 2024
    Report Date
    February 12, 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: 2429304-2024-0000430. THIS REPORT IS RELATED TO (B)(6). THE DEVICE EVALUATION 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 INFORMATION INADVERTENTLY LEFT OUT (B5, H3, LM INVESTIGATION, AND DEVICE EVALUATION). THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED MALFUNCTION WAS NOT REPRODUCED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, NO DEFECT WAS OBSERVED. THEREFORE, THE 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. DUE TO THE PERFORATION, THE PATIENT HAD TO HAVE A RIGHT HEMICOLECTOMY. 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 MULTIPLE TIMES BUT NOT RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS DIAGNOSTIC COLONOSCOPY. THERE WAS NO DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ADDITIONALLY, THE RIGHT HEMICOLECTOMY WAS NOT PREVIOUSLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712986 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UCR 04953170239113

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention EVIS EXERA II COLONOVIDEOSCOPE: SN (B)(6).