The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: before advancing the instrument through the flexible bronchoscope, retract brush into catheter by pulling the brush handle back approximately 5 cm or until brush tip is flush with distal end of catheter.The catheter and protective tip protect the bristles from some of the contaminating organisms that may be picked up while passing it through the flexible bronchoscope.This issue will continue to be monitored through the complaint system to assure patient safety.
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The customer reported that the device, 129r, was being used on (b)(6) 2021 during a bronchoscopy procedure and when they ¿deployed the brush it broke off in the patient.We were able to retrieve the brush out of the patient.¿ there was no report of impact or injury to the patient.The procedure was completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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