The System is ideal for general surgery and specialty surgeries not requiring advanced modes. Warranty: Certified Pre-Owned: 1 Year. Factory New: 2 Years. The System provides state-of-the-art technology in an easy to use format. Modes include pure and blend cut, standard and spray coag, and micro and macro bipolar settings.
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Tried a new handpiece and the problem persisted. Switched to a new cautery. It was also reported, "not sure if doctor received treatment. Manufacturer Narrative This is an fda reportable event due to a an injury received by end-user and treatment, if any, is unknown. The system esu, electrosurgical unit, is a device, in conjunction with connected accessories, that is intended to produce high-frequency electrical energy for the controlled destruction of tissue.
Per b 4 , a full diagnostic test was done on the unit and the unit checked out without any problems noted, and, the unit was reported as performing as expected. Without examination of the actual unit by conmed corporation, there is no conclusive proof that the suspect device failed to meet specifications during the procedural treatment of the patient.
The suspect device is not conclusively at fault for the incident, the incident has been determined as not caused by the esu, based on the evaluation by the end-user facility bioengineer. The complaint investigation has not identified a manufacturing or component defect and the resulting injury has been determined as not caused by the esu; therefore, corrective action is not warranted at the present time.
Conmed is considering this complaint closed. Device not being returned to conmed.
ConMed System 2450 Cart
Conmed System 2450
ConMed 2450 Electrosurgical Unit