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TRIO Handpiece
OMNIGUIDE, INC. · Model 1 · UDI-DI 00852306007708
1
510(k) clearances
118,289
Adverse events (469 deaths)
644
Recalls
858
Facilities
Description
The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact handheld disposable surgical instrument. It enables a surgeon to provide fluid suction, bipolar cautery and CO2 laser energy delivered via a flexible OmniGuide fiber for minimally invasive surgery. The handpiece is delivered sterile, and is intended for one-time use only. TRIO has been validated to be used with the Valleylab Triad or Valleylab Force FX.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Olympus Corporation of the Americas | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-02 | Maquet Cardiovascular, LLC | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-2878 |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-02-25 | Olympus Corporation of the Americas | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For |
| 2026-02-25 | Olympus Corporation of the Americas | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.