International safety notice
Confirmed cases in foreign countries where the device could not be removed from the gastrointestinal tract and had to be surgically removed. did. We conduct a risk assessment, including investigation of adverse events and complaints, and the rotation function of the device stops for some reason during treatment. However, we have confirmed that the device may be difficult to insert and remove, so we have decided to recall the device. Ta.
Japan / PMDA Recalls · JPN · Jul 14, 2023
Key facts
| Title | Confirmed cases in foreign countries where the device could not be removed from the gastrointestinal tract and had to be surgically removed. did. We conduct a risk assessment, including investigation of adverse events and complaints, and the rotation function of the device stops for some reason during treatment. However, we have confirmed that the device may be difficult to insert and remove, so we have decided to recall the device. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Video flexible enteroscope (2) Overtube (3) Endoscope peripheral controller Brand name: (1) Gastrointestinal videoscope OLYMPUS PSF-1 (2) Disposable power spiral tube DPS T-1 (3) Power spiral control unit PSCU |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | 1100401, 1100635, 1100508, 1100503, 1100459, 1200620, 1100449, 1100524, 1100573, 1100419, 1100565, 1100572 and 228 more |
| Date | Jul 14, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1