Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-09-11 | NAI | No action indicated | Intersurgical Inc | 0 |
| 2024-09-11 | NAI | No action indicated | Intersurgical Inc | 0 |
| 2018-11-01 | NAI | No action indicated | Intersurgical Inc | 0 |
| 2018-11-01 | NAI | No action indicated | Intersurgical Inc | 0 |
| 2016-11-18 | VAI | Voluntary action indicated | Intersurgical Inc | 0 |
| 2016-11-18 | VAI | Voluntary action indicated | Intersurgical Inc | 0 |
| 2014-10-29 | VAI | Voluntary action indicated | Intersurgical Inc | 3 |
| 2014-10-29 | VAI | Voluntary action indicated | Intersurgical Inc | 3 |
| 2011-12-30 | WL | Warning Letter | Intersurgical, Ltd. | — |
| 2011-12-30 | WL | Warning Letter | Intersurgical, Ltd. | — |
| 2011-12-21 | VAI | Voluntary action indicated | Intersurgical Inc | 1 |
| 2011-12-21 | VAI | Voluntary action indicated | Intersurgical Inc | 1 |
| 2011-07-14 | OAI | Official action indicated | Intersurgical, Ltd. | 0 |
| 2011-07-14 | OAI | Official action indicated | Intersurgical, Ltd. | 0 |
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