International safety notice
The results of a close examination of cases where the needle catheter, which is a component of the BioBlade laser system, broke or bent. As a result, it was discovered that there were some parts where the inner diameter was smaller than the standard. In August 2021, in addition to a 100% visual inspection, we will conduct a 100% inspection of the inner diameter of the insertion tube using a pin gauge. We have been implementing it since then. Since the standard may be small, we have decided to collect it after securing stock.
Japan / PMDA Recalls · JPN · Sep 7, 2022
Key facts
| Title | The results of a close examination of cases where the needle catheter, which is a component of the BioBlade laser system, broke or bent. As a result, it was discovered that there were some parts where the inner diameter was smaller than the standard. In August 2021, in addition to a 100% visual inspection, we will conduct a 100% inspection of the inner diameter of the insertion tube using a pin gauge. We have been implementing it since then. Since the standard may be small, we have decided to collect it after securing stock. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: PDT Semiconductor Sales name: BioBlade laser system |
| Manufacturer | Rakuten Medical Co., Ltd. |
| Models | 1000000032, 1000000163, 1000000165, 1000000048, 1000000119, 1000000156, 1000000105, 1000000154, 1000000033, 1000000065, 1000000157, 1000000047 and 1 more |
| Date | Sep 7, 2022 |
| 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