DUODENOVIDEOSCOPE
This device is manufactured by AIZU OLYMPUS CO, OLYMPUS AMERICA, OLYMPUS CORPORATION OF THE AMERICAS, OLYMPUS MEDICAL SYSTEMS CORP, OLYMPUS MEDICAL SYSTEMS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 2 | Patient |
| 2024 | Foreign Body In Patient | 6 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Suction Failure | 1 | Device |
| 2024 | Structural Problem | 1 | Device |
| 2024 | Separation Problem | 2 | Device |
| 2024 | Residue After Decontamination | 2 | Device |
| 2024 | Positioning Failure | 1 | Device |
| 2024 | Physical Resistance/Sticking | 1 | Device |
| 2024 | Peeled/Delaminated | 2 | Device |
| 2024 | Optical Discoloration | 4 | Device |
| 2024 | Microbial Contamination of Device | 15 | Device |
| 2024 | Mechanical Problem | 111 | Device |
| 2024 | Mechanical Jam | 3 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Separation | 4 | Device |
| 2024 | Material Puncture/Hole | 1 | Device |
| 2024 | Material Erosion | 2 | Device |
| 2024 | Material Discolored | 6 | Device |
| 2024 | Gas/Air Leak | 1 | Device |
| 2024 | Failure to Clean Adequately | 114 | Device |
| 2024 | Device Reprocessing Problem | 15 | Device |
| 2024 | Detachment of Device or Device Component | 28 | Device |
| 2024 | Crack | 2 | Device |
| 2024 | Corroded | 2 | Device |
| 2024 | Contamination | 1 | Device |
| 2024 | Complete Blockage | 1 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Break | 2 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Laceration(s) of Esophagus | 2 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Foreign Body In Patient | 2 | Patient |
| 2023 | Cough | 1 | Patient |
| 2023 | Adult Respiratory Distress Syndrome | 2 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Separation Problem | 1 | Device |
| 2023 | Peeled/Delaminated | 1 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | Microbial Contamination of Device | 31 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Mechanical Jam | 4 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Separation | 2 | Device |
| 2023 | Material Protrusion/Extrusion | 1 | Device |
| 2023 | Material Discolored | 2 | Device |
| 2023 | Leak/Splash | 4 | Device |
| 2023 | Image Orientation Incorrect | 1 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Failure to Clean Adequately | 70 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult to Advance | 2 | Device |
| 2023 | Device Reprocessing Problem | 13 | Device |
| 2023 | Device Damaged by Another Device | 1 | Device |
| 2023 | Detachment of Device or Device Component | 37 | Device |
| 2023 | Corroded | 1 | Device |
| 2023 | Contamination /Decontamination Problem | 1 | Device |
| 2023 | Contamination | 4 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2022 | Perforation | 1 | Patient |
| 2022 | Foreign Body In Patient | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Separation Problem | 5 | Device |
| 2022 | Retraction Problem | 1 | Device |
| 2022 | Premature Separation | 1 | Device |
| 2022 | Microbial Contamination of Device | 18 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Puncture/Hole | 1 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Loss of or Failure to Bond | 1 | Device |
| 2022 | Flushing Problem | 2 | Device |
| 2022 | Failure to Clean Adequately | 7 | Device |
| 2022 | Device Reprocessing Problem | 7 | Device |
| 2022 | Device Handling Problem | 1 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Detachment of Device or Device Component | 20 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2022 | Contamination /Decontamination Problem | 2 | Device |
| 2022 | Contamination | 6 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Foreign Body In Patient | 2 | Patient |
| 2021 | Detachment of Device or Device Component | 14 | Device |
| 2021 | Component Missing | 2 | Device |
| 2020 | Unspecified Tissue Injury | 1 | Patient |
| 2020 | Laceration(s) of Esophagus | 1 | Patient |
| 2020 | Use of Device Problem | 1 | Device |
| 2020 | Crack | 1 | Device |
| 2020 | Contamination | 1 | Device |
| 2019 | Microbial Contamination of Device | 12 | Device |
| 2019 | Material Separation | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2018 | Microbial Contamination of Device | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2016 | Unspecified Infection | 2 | Patient |
| 2016 | Purulent Discharge | 1 | Patient |
| 2016 | Contamination /Decontamination Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 1 | Device |