EVIS LUCERA ELITE COLONOVIDEOSCOPE

COLONOVIDEOSCOPE

This device is manufactured by AIZU OLYMPUS CO.

The following problems were reported about this device:

Year Description Events/year Type
2024 No Display/Image 5 Device
2024 Microbial Contamination of Device 2 Device
2024 Mechanical Problem 1 Device
2024 Improper or Incorrect Procedure or Method 1 Device
2024 Image Display Error/Artifact 1 Device
2024 Failure to Clean Adequately 251 Device
2024 Device Reprocessing Problem 11 Device
2024 Corroded 1 Device
2024 Connection Problem 1 Device
2024 Communication or Transmission Problem 72 Device
2023 Hemorrhage/Blood Loss/Bleeding 2 Patient
2023 Bowel Perforation 2 Patient
2023 Restricted Flow rate 1 Device
2023 Poor Quality Image 2 Device
2023 Particulates 1 Device
2023 Output Problem 1 Device
2023 Obstruction of Flow 3 Device
2023 No Display/Image 29 Device
2023 Moisture Damage 2 Device
2023 Microbial Contamination of Device 9 Device
2023 Mechanical Problem 1 Device
2023 Intermittent Continuity 2 Device
2023 Incomplete or Inadequate Connection 2 Device
2023 Image Display Error/Artifact 2 Device
2023 Fluid/Blood Leak 1 Device
2023 Failure to Clean Adequately 201 Device
2023 Electrical Shorting 1 Device
2023 Electrical /Electronic Property Problem 5 Device
2023 Display or Visual Feedback Problem 12 Device
2023 Device Reprocessing Problem 65 Device
2023 Device Handling Problem 1 Device
2023 Device Contamination with Chemical or Other Material 4 Device
2023 Corroded 2 Device
2023 Contamination /Decontamination Problem 5 Device
2023 Contamination 27 Device
2023 Connection Problem 1 Device
2023 Component or Accessory Incompatibility 1 Device
2023 Component Incompatible 2 Device
2023 Complete Blockage 3 Device
2023 Communication or Transmission Problem 105 Device
2023 Break 1 Device
2023 Adverse Event Without Identified Device or Use Problem 2 Device
2022 Unspecified Hepatic or Biliary Problem 1 Patient
2022 Perforation 1 Patient
2022 Hemorrhage/Blood Loss/Bleeding 1 Patient
2022 Residue After Decontamination 1 Device
2022 Output Problem 6 Device
2022 No Display/Image 23 Device
2022 Moisture Damage 2 Device
2022 Microbial Contamination of Device 6 Device
2022 Intermittent Continuity 2 Device
2022 Incomplete or Inadequate Connection 8 Device
2022 Image Display Error/Artifact 3 Device
2022 Failure to Clean Adequately 33 Device
2022 Electrical Power Problem 1 Device
2022 Electrical /Electronic Property Problem 1 Device
2022 Display or Visual Feedback Problem 25 Device
2022 Device Reprocessing Problem 11 Device
2022 Device Contamination with Chemical or Other Material 1 Device
2022 Device Contamination with Body Fluid 1 Device
2022 Detachment of Device or Device Component 1 Device
2022 Contamination /Decontamination Problem 8 Device
2022 Contamination 13 Device
2022 Communication or Transmission Problem 31 Device
2022 Break 1 Device
2022 Adverse Event Without Identified Device or Use Problem 1 Device
2021 Poor Quality Image 1 Device
2021 No Display/Image 3 Device
2021 Image Display Error/Artifact 1 Device
2021 Display or Visual Feedback Problem 2 Device
2021 Connection Problem 1 Device