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US Endoscopy · Model 00711843 · UDI-DI 00724995180690
KNS
Prescription
1
510(k) clearances
17,476
Adverse events (81 deaths)
125
Recalls
118
Facilities
Description
The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
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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.