International safety notice
This product is an endoscopic active instrument that performs procedures such as tissue cutting during endoscopic surgery. We have received a report from an overseas manufacturer that objects falling into the body were observed when using this product. As a result, if the blades at the tip of this product are poorly engaged, the blade may break if excessive force is applied when operating the handle of this product. It has been found that there is a possibility of excessive rubbing and, in rare cases, the formation of metal fragments. Therefore, we have decided to implement a voluntary recall of specific lots of this product.
Japan / PMDA Recalls · JPN · May 27, 2021
Key facts
| Title | This product is an endoscopic active instrument that performs procedures such as tissue cutting during endoscopic surgery. We have received a report from an overseas manufacturer that objects falling into the body were observed when using this product. As a result, if the blades at the tip of this product are poorly engaged, the blade may break if excessive force is applied when operating the handle of this product. It has been found that there is a possibility of excessive rubbing and, in rare cases, the formation of metal fragments. Therefore, we have decided to implement a voluntary recall of specific lots of this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Endoscopic active instrument for single-use radiofrequency procedures Sales name: LAGIS disposable instruments |
| Manufacturer | Proceed Co., Ltd. |
| Models | P2010015, P2103043, P2007039, P2011026, P2101031, P2012071 |
| Date | May 27, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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