DUODENOVIDEOSCOPE
This device is manufactured by AIZU OLYMPUS CO, OLYMPUS AMERICA, OLYMPUS CORPORATION OF THE AMERICAS, OLYMPUS MED SYSTEM CORP, OLYMPUS MEDICAL SYSTEMS and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Hepatic or Biliary Problem | 1 | Patient |
| 2024 | Perforation | 1 | Patient |
| 2024 | Pancreatitis | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Peeled/Delaminated | 3 | Device |
| 2024 | Partial Blockage | 1 | Device |
| 2024 | Obstruction of Flow | 1 | Device |
| 2024 | Moisture or Humidity Problem | 1 | Device |
| 2024 | Microbial Contamination of Device | 2 | Device |
| 2024 | Material Separation | 8 | Device |
| 2024 | Material Discolored | 6 | Device |
| 2024 | Leak/Splash | 4 | Device |
| 2024 | Failure to Clean Adequately | 67 | Device |
| 2024 | Device Reprocessing Problem | 5 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Crack | 17 | Device |
| 2024 | Corroded | 3 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 3 | Patient |
| 2023 | Sepsis | 3 | Patient |
| 2023 | Pancreatitis | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Bacterial Infection | 3 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Positioning Failure | 1 | Device |
| 2023 | Physical Resistance/Sticking | 1 | Device |
| 2023 | Peeled/Delaminated | 3 | Device |
| 2023 | Optical Discoloration | 1 | Device |
| 2023 | Microbial Contamination of Device | 8 | Device |
| 2023 | Material Separation | 1 | Device |
| 2023 | Material Puncture/Hole | 1 | Device |
| 2023 | Material Discolored | 2 | Device |
| 2023 | Leak/Splash | 3 | Device |
| 2023 | Image Display Error/Artifact | 1 | Device |
| 2023 | Failure to Clean Adequately | 92 | Device |
| 2023 | Difficult or Delayed Positioning | 1 | Device |
| 2023 | Device Reprocessing Problem | 18 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Defective Component | 1 | Device |
| 2023 | Crack | 11 | Device |
| 2023 | Corroded | 2 | Device |
| 2023 | Contamination | 19 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Blocked Connection | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Pancreatitis | 1 | Patient |
| 2022 | Bacterial Infection | 2 | Patient |
| 2022 | Abdominal Pain | 1 | Patient |
| 2022 | Peeled/Delaminated | 1 | Device |
| 2022 | Optical Discoloration | 1 | Device |
| 2022 | Microbial Contamination of Device | 5 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Fluid/Blood Leak | 1 | Device |
| 2022 | Failure to Clean Adequately | 40 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Reprocessing Problem | 11 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2022 | Crack | 3 | Device |
| 2022 | Contamination /Decontamination Problem | 7 | Device |
| 2022 | Contamination | 39 | Device |
| 2022 | Blocked Connection | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | Microbial Contamination of Device | 2 | Device |
| 2021 | Contamination | 1 | Device |
| 2020 | Microbial Contamination of Device | 14 | Device |
| 2020 | Device Reprocessing Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Problem with Sterilization | 1 | Device |
| 2019 | No Display/Image | 2 | Device |
| 2019 | Microbial Contamination of Device | 56 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Failure to Clean Adequately | 1 | Device |
| 2019 | Failure to Advance | 1 | Device |
| 2019 | Entrapment of Device | 1 | Device |
| 2019 | Device Reprocessing Problem | 1 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2019 | Complete Blockage | 1 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2018 | Sticking | 1 | Device |
| 2018 | Optical Distortion | 1 | Device |
| 2018 | Optical Discoloration | 1 | Device |
| 2018 | No Apparent Adverse Event | 1 | Device |
| 2018 | Microbial Contamination of Device | 89 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2018 | Improper Chemical Reaction | 1 | Device |
| 2018 | Firing Problem | 1 | Device |
| 2018 | Failure to Clean Adequately | 1 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Device Reprocessing Problem | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2017 | Microbial Contamination of Device | 70 | Device |
| 2017 | Material Too Rigid or Stiff | 1 | Device |
| 2017 | Detachment Of Device Component | 2 | Device |
| 2017 | Deformation Due to Compressive Stress | 1 | Device |
| 2017 | Complete Blockage | 1 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 7 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2016 | Poor Quality Image | 1 | Device |
| 2016 | Moisture or Humidity Problem | 1 | Device |
| 2016 | Microbial Contamination of Device | 20 | Device |
| 2016 | Material Integrity Problem | 1 | Device |
| 2016 | Leak/Splash | 2 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2016 | Design/structure problem | 1 | Device |
| 2016 | Crack | 2 | Device |
| 2016 | Complete Blockage | 1 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2015 | Microbial Contamination of Device | 7 | Device |
| 2015 | Device Reprocessing Problem | 1 | Device |
| 2015 | Design/structure problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Microbial Contamination of Device | 11 | Device |
| 2014 | Device Reprocessing Problem | 1 | Device |
| 2014 | Device Disinfection Or Sterilization Issue | 1 | Device |
| 2014 | Contamination | 5 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2013 | Microbial Contamination of Device | 1 | Device |
| 2013 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 2 | Device |