RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Additional Manufacturer Narrative

(B)(4). NO PHYSICAL SAMPLE WAS RETURNED FOR THIS COMPLAINT. INSTEAD, THE CUSTOMER PROVIDED A PICTURE SHOWING THREE USED LEFT BRONCHUS ENDOBRONCHIAL TUBES WITH DEFLATED BALLOONS. HOWEVER, IN THE ABSENCE OF ACTUAL RETURNED SAMPLES, THE REPORTED COMPLAINT OF CUFF LEAKAGE COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR LOT 40E24G4011 WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THERE IS VERY LIMITED INFORMATION ON THE COMPLAINT AND FURTHERMORE NO PHYSICAL INVESTIGATION, OR ASSESSMENT HAS BEEN CONDUCTED ON THE DEFECTIVE PART. SINCE THERE WAS NO SAMPLE RETURNED FOR THIS COMPLAINT, FURTHER INVESTIGATION FOR THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE, THIS COMPLAINT OF CUFF LEAKAGE COULD NOT BE CONFIRMED. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT "ACCORDING TO [DOCTOR], A PATIENT WAS IN FOR A THORACIC PROCEDURE, THE FIRST BRONCHIAL TUBE WAS INSERTED WITHOUT PRIOR CHECKING OF THE CUFF, AFTER INSERTION IT WAS FOUND TO BE LEAKING. A SECOND ONE WAS CHECKED FOR LEAKAGE PRIOR AND FOUND TO BE OK WITH NO LEAK, AFTER CAREFUL INSERTION, IT WAS FOUND TO BE LEAKING AS WELL. AND THE THIRD TUBE, SIZE 39, TOO AFTER IT WAS INSPECTED FOR LEAKAGE, CAREFULLY INSERTED BUT WAS FOUND TO BE LEAKING FROM THE CUFF - ONLY THE FOURTH TUBE WAS SUCCESSFULLY INSERTED". ASSOCIATED MDRS 8040412-2025-00207, 8040412-2025-00208.

Additional Manufacturer Narrative

QN# (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "ACCORDING TO THE [DOCTOR], A PATIENT WAS IN FOR A THORACIC PROCEDURE, THE FIRST BRONCHIAL TUBE WAS INSERTED WITHOUT PRIOR CHECKING OF THE CUFF, AFTER INSERTION IT WAS FOUND TO BE LEAKING. A SECOND ONE WAS CHECKED FOR LEAKAGE PRIOR AND FOUND TO BE OK WITH NO LEAK, AFTER CAREFUL INSERTION, IT WAS FOUND TO BE LEAKING AS WELL. AND THE THIRD TUBE, SIZE 39, TOO AFTER IT WAS INSPECTED FOR LEAKAGE, CAREFULLY INSERTED BUT WAS FOUND TO BE LEAKING FROM THE CUFF - ONLY THE FOURTH TUBE WAS SUCCESSFULLY INSERTED". ASSOCIATED MDRS 8040412-2025-00207, 8040412-2025-00208.