ULTRASOUND GASTROVIDEOSCOPE
This device is manufactured by AIZU OLYMPUS CO, OLYMPUS MEDICAL SYSTEMS CORP, OLYMPUS MEDICAL SYSTEMS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unintended Movement | 1 | Device |
| 2024 | Separation Problem | 11 | Device |
| 2024 | Scratched Material | 4 | Device |
| 2024 | Premature Separation | 1 | Device |
| 2024 | Peeled/Delaminated | 7 | Device |
| 2024 | Partial Blockage | 1 | Device |
| 2024 | Optical Obstruction | 1 | Device |
| 2024 | No Display/Image | 3 | Device |
| 2024 | Microbial Contamination of Device | 16 | Device |
| 2024 | Material Split, Cut or Torn | 8 | Device |
| 2024 | Material Separation | 48 | Device |
| 2024 | Material Puncture/Hole | 3 | Device |
| 2024 | Material Frayed | 1 | Device |
| 2024 | Material Discolored | 3 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Leak/Splash | 1 | Device |
| 2024 | Failure to Seal | 1 | Device |
| 2024 | Failure to Clean Adequately | 31 | Device |
| 2024 | Device Reprocessing Problem | 6 | Device |
| 2024 | Detachment of Device or Device Component | 3 | Device |
| 2024 | Degraded | 4 | Device |
| 2024 | Crack | 12 | Device |
| 2024 | Corroded | 1 | Device |
| 2024 | Contamination | 5 | Device |
| 2024 | Component Missing | 2 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Activation, Positioning or Separation Problem | 1 | Device |
| 2023 | Perforation | 3 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Separation Problem | 1 | Device |
| 2023 | Scratched Material | 4 | Device |
| 2023 | Pressure Problem | 1 | Device |
| 2023 | Pitted | 2 | Device |
| 2023 | Peeled/Delaminated | 35 | Device |
| 2023 | Particulates | 1 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | No Display/Image | 6 | Device |
| 2023 | Microbial Contamination of Device | 29 | Device |
| 2023 | Mechanical Problem | 6 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Too Rigid or Stiff | 1 | Device |
| 2023 | Material Split, Cut or Torn | 10 | Device |
| 2023 | Material Separation | 34 | Device |
| 2023 | Material Rupture | 1 | Device |
| 2023 | Material Puncture/Hole | 1 | Device |
| 2023 | Material Protrusion/Extrusion | 2 | Device |
| 2023 | Material Discolored | 2 | Device |
| 2023 | Material Deformation | 2 | Device |
| 2023 | Loss of or Failure to Bond | 2 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Failure to Clean Adequately | 31 | Device |
| 2023 | Difficult to Open or Close | 1 | Device |
| 2023 | Difficult to Insert | 1 | Device |
| 2023 | Device Reprocessing Problem | 11 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2023 | Detachment of Device or Device Component | 3 | Device |
| 2023 | Deformation Due to Compressive Stress | 1 | Device |
| 2023 | Defective Component | 2 | Device |
| 2023 | Crack | 11 | Device |
| 2023 | Contamination /Decontamination Problem | 1 | Device |
| 2023 | Contamination | 5 | Device |
| 2023 | Component Missing | 13 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Break | 6 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Perforation | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Separation Problem | 1 | Device |
| 2022 | Peeled/Delaminated | 46 | Device |
| 2022 | Particulates | 1 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | No Display/Image | 2 | Device |
| 2022 | Microbial Contamination of Device | 16 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Material Split, Cut or Torn | 10 | Device |
| 2022 | Material Separation | 7 | Device |
| 2022 | Material Puncture/Hole | 7 | Device |
| 2022 | Material Perforation | 1 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Fluid/Blood Leak | 2 | Device |
| 2022 | Failure to Cut | 1 | Device |
| 2022 | Failure to Clean Adequately | 15 | Device |
| 2022 | Device Reprocessing Problem | 2 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Detachment of Device or Device Component | 3 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Deformation Due to Compressive Stress | 1 | Device |
| 2022 | Crack | 7 | Device |
| 2022 | Contamination /Decontamination Problem | 3 | Device |
| 2022 | Contamination | 9 | Device |
| 2022 | Component Missing | 2 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | No Display/Image | 3 | Device |
| 2021 | Contamination | 1 | Device |
| 2020 | Microbial Contamination of Device | 2 | Device |
| 2020 | Device Dislodged or Dislocated | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Sparking | 1 | Device |
| 2019 | Microbial Contamination of Device | 46 | Device |
| 2019 | Material Discolored | 1 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Excess Flow or Over-Infusion | 1 | Device |
| 2019 | Contamination /Decontamination Problem | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2018 | Microbial Contamination of Device | 23 | Device |
| 2018 | Insufficient Information | 3 | Device |
| 2017 | Temperature Problem | 1 | Device |
| 2017 | Overheating of Device | 1 | Device |
| 2017 | Microbial Contamination of Device | 14 | Device |
| 2017 | Material Puncture/Hole | 1 | Device |
| 2017 | Material Perforation | 1 | Device |
| 2017 | Insufficient Information | 2 | Device |
| 2017 | Contamination /Decontamination Problem | 8 | Device |
| 2016 | Temperature Problem | 1 | Device |
| 2016 | Smoking | 1 | Device |
| 2016 | Overheating of Device | 1 | Device |
| 2016 | Microbial Contamination of Device | 1 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Leak/Splash | 1 | Device |
| 2016 | Device Damaged by Another Device | 1 | Device |
| 2016 | Contamination /Decontamination Problem | 1 | Device |
| 2013 | No Flow | 1 | Device |