COLONOVIDEOSCOPE
This device is manufactured by AIZU OLYMPUS CO, OLYMPUS AMERICA, OLYMPUS CORPORATION OF THE AMERICAS, OLYMPUS MEDICAL SYSTEMS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Perforation | 1 | Patient |
| 2024 | Suction Failure | 1 | Device |
| 2024 | Positioning Failure | 1 | Device |
| 2024 | Partial Blockage | 1 | Device |
| 2024 | Output Problem | 1 | Device |
| 2024 | Obstruction of Flow | 1 | Device |
| 2024 | No Display/Image | 5 | Device |
| 2024 | Misassembled | 1 | Device |
| 2024 | Microbial Contamination of Device | 79 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Mechanical Jam | 1 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Frayed | 1 | Device |
| 2024 | Material Discolored | 1 | Device |
| 2024 | Leak/Splash | 2 | Device |
| 2024 | Inflation Problem | 1 | Device |
| 2024 | Failure to Clean Adequately | 460 | Device |
| 2024 | Difficult to Insert | 1 | Device |
| 2024 | Device Reprocessing Problem | 47 | Device |
| 2024 | Device Markings/Labelling Problem | 1 | Device |
| 2024 | Device Damaged Prior to Use | 1 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Complete Blockage | 2 | Device |
| 2024 | Communication or Transmission Problem | 25 | Device |
| 2024 | Break | 2 | Device |
| 2023 | Tachycardia | 2 | Patient |
| 2023 | Pneumoperitoneum | 2 | Patient |
| 2023 | Perforation | 2 | Patient |
| 2023 | Increased Respiratory Rate | 2 | Patient |
| 2023 | Hepatitis | 3 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 4 | Patient |
| 2023 | Bowel Perforation | 4 | Patient |
| 2023 | Abdominal Distention | 2 | Patient |
| 2023 | Restricted Flow rate | 1 | Device |
| 2023 | Poor Quality Image | 1 | Device |
| 2023 | Particulates | 3 | Device |
| 2023 | Partial Blockage | 2 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | No Display/Image | 6 | Device |
| 2023 | Misassembly During Maintenance/Repair | 1 | Device |
| 2023 | Microbial Contamination of Device | 101 | Device |
| 2023 | Mechanical Problem | 3 | Device |
| 2023 | Mechanical Jam | 2 | Device |
| 2023 | Material Too Rigid or Stiff | 1 | Device |
| 2023 | Material Split, Cut or Torn | 5 | Device |
| 2023 | Material Protrusion/Extrusion | 1 | Device |
| 2023 | Low Readings | 1 | Device |
| 2023 | Inflation Problem | 1 | Device |
| 2023 | Image Display Error/Artifact | 2 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Failure to Clean Adequately | 266 | Device |
| 2023 | Display or Visual Feedback Problem | 2 | Device |
| 2023 | Disconnection | 1 | Device |
| 2023 | Device Reprocessing Problem | 108 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2023 | Detachment of Device or Device Component | 3 | Device |
| 2023 | Contamination /Decontamination Problem | 12 | Device |
| 2023 | Contamination | 18 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Complete Blockage | 3 | Device |
| 2023 | Communication or Transmission Problem | 35 | Device |
| 2023 | Break | 4 | Device |
| 2023 | Blocked Connection | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2022 | Pressure Problem | 1 | Device |
| 2022 | Obstruction of Flow | 2 | Device |
| 2022 | Nonstandard Device | 1 | Device |
| 2022 | No Display/Image | 10 | Device |
| 2022 | Microbial Contamination of Device | 56 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Puncture/Hole | 2 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Incomplete or Inadequate Connection | 3 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2022 | Fluid/Blood Leak | 2 | Device |
| 2022 | Failure to Clean Adequately | 24 | Device |
| 2022 | Electrical Shorting | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 4 | Device |
| 2022 | Device Reprocessing Problem | 15 | Device |
| 2022 | Device Handling Problem | 2 | Device |
| 2022 | Device Difficult to Setup or Prepare | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Corroded | 1 | Device |
| 2022 | Contamination /Decontamination Problem | 6 | Device |
| 2022 | Contamination | 11 | Device |
| 2022 | Communication or Transmission Problem | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2021 | No Display/Image | 14 | Device |