ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

FLEX DEFLECTABLE VIDEOSCOPE

This device is manufactured by AIZU OLYMPUS CO.

The following problems were reported about this device:

Year Description Events/year Type
2024 Signal Artifact/Noise 1 Device
2024 Poor Quality Image 43 Device
2024 Peeled/Delaminated 82 Device
2024 Output Problem 5 Device
2024 Noise, Audible 4 Device
2024 No Display/Image 120 Device
2024 Material Split, Cut or Torn 1 Device
2024 Material Integrity Problem 1 Device
2024 Material Erosion 1 Device
2024 Loss of Data 4 Device
2024 Image Orientation Incorrect 1 Device
2024 Image Display Error/Artifact 3 Device
2024 Failure to Clean Adequately 4 Device
2024 Erratic or Intermittent Display 3 Device
2024 Electrical /Electronic Property Problem 1 Device
2024 Display or Visual Feedback Problem 1 Device
2024 Detachment of Device or Device Component 1 Device
2024 Contamination 1 Device
2024 Connection Problem 1 Device
2024 Communication or Transmission Problem 51 Device
2024 Break 2 Device
2023 Stenosis of the esophagus 1 Patient
2023 Necrosis 1 Patient
2023 Inflammation 1 Patient
2023 Foreign Body In Patient 1 Patient
2023 Dysphagia/ Odynophagia 7 Patient
2023 Unexpected Color 1 Device
2023 Signal Artifact/Noise 5 Device
2023 Self-Activation or Keying 3 Device
2023 Poor Quality Image 51 Device
2023 Peeled/Delaminated 76 Device
2023 Output Problem 2 Device
2023 Noise, Audible 1 Device
2023 No Display/Image 166 Device
2023 Loss of Data 1 Device
2023 Loose or Intermittent Connection 1 Device
2023 Intermittent Continuity 3 Device
2023 Image Orientation Incorrect 1 Device
2023 Image Display Error/Artifact 13 Device
2023 Fogging 1 Device
2023 Failure to Clean Adequately 2 Device
2023 Erratic or Intermittent Display 8 Device
2023 Electrical /Electronic Property Problem 6 Device
2023 Display or Visual Feedback Problem 13 Device
2023 Disconnection 1 Device
2023 Device Damaged Prior to Use 1 Device
2023 Detachment of Device or Device Component 2 Device
2023 Degraded 2 Device
2023 Defective Component 1 Device
2023 Corroded 1 Device
2023 Communication or Transmission Problem 81 Device
2023 Break 1 Device
2023 Application Program Freezes, Becomes Nonfunctional 1 Device
2023 Adverse Event Without Identified Device or Use Problem 7 Device
2022 Signal Artifact/Noise 1 Device
2022 Poor Quality Image 9 Device
2022 Peeled/Delaminated 19 Device
2022 Output Problem 1 Device
2022 No Display/Image 55 Device
2022 Image Display Error/Artifact 8 Device
2022 Erratic or Intermittent Display 2 Device
2022 Electrical Shorting 4 Device
2022 Display or Visual Feedback Problem 6 Device
2022 Display Difficult to Read 2 Device
2022 Corroded 1 Device
2022 Communication or Transmission Problem 13 Device
2022 Break 2 Device