COLONOVIDEOSCOPE
This device is manufactured by AIZU OLYMPUS CO, OLYMPUS CORPORATION OF THE AMERICAS, OLYMPUS MEDICAL SYSTEMS, OLYMPUS MEDICAL SYSTEMS CORP, OLYMPUS MEDICAL SYSTEMS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Separation Problem | 1 | Device |
| 2024 | Radiofrequency Interference (RFI) | 1 | Device |
| 2024 | Microbial Contamination of Device | 2 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Failure to Clean Adequately | 58 | Device |
| 2024 | Device Reprocessing Problem | 8 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Break | 1 | Device |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Bowel Perforation | 1 | Patient |
| 2023 | Microbial Contamination of Device | 10 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Failure to Clean Adequately | 34 | Device |
| 2023 | Device Reprocessing Problem | 21 | Device |
| 2023 | Device Damaged by Another Device | 1 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Contamination /Decontamination Problem | 1 | Device |
| 2023 | Contamination | 4 | Device |
| 2023 | Complete Blockage | 1 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2022 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2022 | Microbial Contamination of Device | 9 | Device |
| 2022 | Increase in Pressure | 1 | Device |
| 2022 | Failure to Disinfect | 2 | Device |
| 2022 | Failure to Clean Adequately | 10 | Device |
| 2022 | Erratic or Intermittent Display | 1 | Device |
| 2022 | Device Reprocessing Problem | 5 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2022 | Contamination | 4 | Device |
| 2022 | Communication or Transmission Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Microbial Contamination of Device | 39 | Device |
| 2019 | Material Protrusion/Extrusion | 1 | Device |
| 2019 | Detachment of Device or Device Component | 1 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Peeled/Delaminated | 1 | Device |
| 2018 | Microbial Contamination of Device | 71 | Device |
| 2018 | Material Protrusion/Extrusion | 1 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Difficult To Position | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Component Falling | 1 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2017 | Moisture or Humidity Problem | 1 | Device |
| 2017 | Microbial Contamination of Device | 77 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Material Twisted/Bent | 1 | Device |
| 2017 | Material Rupture | 1 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2017 | Fluid/Blood Leak | 3 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Detachment Of Device Component | 3 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2016 | Microbial Contamination of Device | 22 | Device |
| 2016 | Detachment of Device or Device Component | 3 | Device |
| 2016 | Complete Blockage | 1 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Microbial Contamination of Device | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2014 | Increase in Pressure | 1 | Device |
| 2014 | Device Reprocessing Problem | 1 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2013 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |