International safety notice
While continuing to monitor complaints collected from the market, we have revised the following (1) and (2). As a result of a risk assessment, we have decided to voluntarily recall the equipment before the design change. (1) Do not use the device with cracks or remove the endoscope with mucous membranes stuck inside the device due to the suction function. An event that damages the mucous membrane (hereinafter referred to as a mucosal injury event) (2) If the device is used with cracks or if it is not securely attached to the tip of the endoscope, Event of falling off from the endoscope (hereinafter referred to as falling off event)
Japan / PMDA Recalls · JPN · Apr 24, 2023
Key facts
| Title | While continuing to monitor complaints collected from the market, we have revised the following (1) and (2). As a result of a risk assessment, we have decided to voluntarily recall the equipment before the design change. (1) Do not use the device with cracks or remove the endoscope with mucous membranes stuck inside the device due to the suction function. An event that damages the mucous membrane (hereinafter referred to as a mucosal injury event) (2) If the device is used with cracks or if it is not securely attached to the tip of the endoscope, Event of falling off from the endoscope (hereinafter referred to as falling off event) |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Endoscope component adapter Sales name: Disposable tip cover MAJ-2315 |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | H1819, H1X18, H0615, H0X16, H8730, H8920, H0717, H0Y09, H0603, H0623, H8Y05, H0414 and 158 more |
| Date | Apr 24, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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