International safety notice
Regarding the product manufactured and sold by our company, in a foreign country, the outer cylindrical electrode fell from the handle during surgery. One case of health damage (retinal tear) occurred. As a result of our investigation, we found that during the manufacturing process, when removing and trimming unnecessary parts near the border between the handle and the outer cylinder electrode, Scratches may occur when the cutting tool comes into contact with the outer cylindrical electrode, and fragile products that lack mechanical strength against external forces may be mixed in. It turns out that this is caused by. The company has decided to voluntarily recall all products manufactured after September 2022 due to a large number of complaints regarding falling outer cylinder electrodes. It has been decided.
Japan / PMDA Recalls · JPN · Nov 15, 2024
Key facts
| Title | Regarding the product manufactured and sold by our company, in a foreign country, the outer cylindrical electrode fell from the handle during surgery. One case of health damage (retinal tear) occurred. As a result of our investigation, we found that during the manufacturing process, when removing and trimming unnecessary parts near the border between the handle and the outer cylinder electrode, Scratches may occur when the cutting tool comes into contact with the outer cylindrical electrode, and fragile products that lack mechanical strength against external forces may be mixed in. It turns out that this is caused by. The company has decided to voluntarily recall all products manufactured after September 2022 due to a large number of complaints regarding falling outer cylinder electrodes. It has been decided. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: バイポーラ electrode Sales name: Disposable bipolar electrode pencil type |
| Manufacturer | RL Medical Co., Ltd. |
| Models | 230124, 230315, 220906, 231124, 240308, SR-14-5011-5, 221230, 240412, 230502, 230404, 230417, 221228 and 7 more |
| Date | Nov 15, 2024 |
| 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