RUSCH BRONCHOPART DOUBLE LUMEN LEFT
Received Nov 20, 2025 · Event occurred Oct 31, 2025
Report 8040412-2025-00261 · MDR key 23602991
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalModel number
IPN047053Catalog number
116100-000370
Lot number
40E25C0195
Product problems
- Nonstandard Device
- Nonstandard Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT " DURING THORACIC SURGERY, ONE OF OUR DOUBLE-LUMEN TUBES HAD A NARROWING. IT WAS NOT POSSIBLE TO INSERT A BRONCHOSCOPE TO CHECK THE POSITION, NOR WAS IT POSSIBLE TO INSERT A SUCTION CATHETER. THE PATIENT WAS REINTUBATED AND THEN EVERYTHING WENT SMOOTHLY. THE PATIENT IS DOING WELL AND, APART FROM THE REINTUBATION, NO FURTHER INTERVENTION WAS NECESSARY. "
Additional Manufacturer Narrative
(B)(4). THE REPORTED ISSUE 'TUBE TOO NARROW' COULD NOT BE CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED AN ACTUAL SAMPLE FOR EVALUATION. BASED ON VISUAL AND DIMENSIONAL INSPECTION PERFORMED ON ACTUAL SAMPLE RECEIVED, NO DEFECT WAS OBSERVED. THE DIMENSIONAL INSPECTION (ID) RESULT SHOWS THAT THE TUBE ID EXCEEDED THE MINIMUM REQUIREMENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION OF THE RETURNED COMPLAINT DEVICE, NO PROBLEM WAS FOUND ON THE RETURNED SAMPLE.
Description of Event or Problem
IT WAS REPORTED THAT " DURING THORACIC SURGERY, ONE OF OUR DOUBLE-LUMEN TUBES HAD A NARROWING. IT WAS NOT POSSIBLE TO INSERT A BRONCHOSCOPE TO CHECK THE POSITION, NOR WAS IT POSSIBLE TO INSERT A SUCTION CATHETER. THE PATIENT WAS REINTUBATED AND THEN EVERYTHING WENT SMOOTHLY. THE PATIENT IS DOING WELL AND, APART FROM THE REINTUBATION, NO FURTHER INTERVENTION WAS NECESSARY. "
Additional Manufacturer Narrative
(B)(4).