It was reported that, after a tonsillectomy procedure performed with an ent coblation wand on which the patient had a #4.0 ped shiley tracheostomy tube in place at time of surgery, and the procedure was performed in context of later decannulation because it was safer without tonsils potentially obstructing the airway and tonsillectomy will be easier to perform with tracheostomy tube still in place.This is because the patient has h/o rubinstein-taybi syndrome.Due to co-morbidities the patient arrived with an infection, tachypneic and with high-grade fever.The trach cultures grew staph aureus.The patient was discharged after 3 days.No further information is available.
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H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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