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Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Search FDA. Food and Drug Administration. For Government For Press. Adverse Events. CFR Title Radiation-Emitting Products. X-Ray Assembler. Medsun Reports. New Search. Date Initiated by Firm February 20, Coblator II System, V. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand.

The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology ENT surgery. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees.

The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at , option 3. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.


Coblator Machine

Coblation is operated in low temperature, so it is proposed that tonsillectomy with coblation involves less postoperative pain and allows accelerated healing of the tonsillar fossae compared with other methods involving heat driven processes. However, the results of the previous studies showed that the effect of coblation tonsillectomy has been equivocal in terms of postoperative pain and hemorrhage. Though, most of the previous studies which evaluated coblation tonsillectomy were performed in children. Recently, electrocautery tonsillectomy has been used most widely because of the reduced intraoperative blood loss and shorter operative time compared to other techniques. This prospective study compared intraoperative records and postoperative clinical outcomes in adolescents and adults following coblation and electrocautery tonsillectomies.


Class 2 Device Recall Coblator II System


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