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GI2000
Cintron Medical Corporation · Model 30-0026-xxx · UDI-DI 00860014201004
GEI
Prescription
1
510(k) clearances
118,289
Adverse events (469 deaths)
644
Recalls
859
Facilities
Description
The gi2000 is an electrosurgical generator for use in flexible endoscopic clinical settings, employing high-frequency energies to carry out cutting and coagulation of tissue during gastrointestinal surgical procedures. This isolated output electrosurgical unit (ESU) includes all standard features commonly utilized in a broad spectrum of gastrointestinal surgical procedures, encompassing monopolar cutting, monopolar coagulation, and monopolar spray coagulation, along with bipolar coagulation.
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.