RUSCH BRONCHOPART DOUBLE LUMEN LEFT

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "CUSTOMER NOTICED LEAKS IN THE TRACHEAL CUFF OF THE DL TUBE! IT WAS REPLACED BY ANOTHER DEVICE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM."

Description of Event or Problem

IT WAS REPORTED THAT: "CUSTOMER NOTICED LEAKS IN THE TRACHEAL CUFF OF THE DL TUBE! IT WAS REPLACED BY ANOTHER DEVICE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM."

Additional Manufacturer Narrative

(B)(4) THE COMPLAINT OF CUFF LEAKAGE WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE ACTUAL SAMPLE WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING CONFIRMED CUFF DEFLATION AFTER INFLATION. VISUAL EXAMINATION IDENTIFIED A TEAR LOCALIZED AND LINEAR, PRESENTING AS AN IRREGULAR SLIT WITH ROUGH, UNEVEN EDGES. UNDER MAGNIFIED INSPECTION, THE DEFECT EXHIBITED A NON-UNIFORM, JAGGED MORPHOLOGY CONSISTENT WITH A MECHANICALLY INDUCED CUT RATHER THAN A PROCESS-DRIVEN FAILURE. THE CONFINED NATURE OF THE SLIT AND THE ABRUPT TEAR PATTERN ARE CHARACTERISTIC OF EXTERNAL MECHANICAL DAMAGE RATHER THAN A DEFECT ARISING FROM MANUFACTURING MATERIAL OR PROCESS CONDITIONS. WITH THE AVAILABLE EVIDENCE, THE DEFECT IS UNLIKELY TO BE ASSOCIATED WITH ANY MANUFACTURING MATERIAL OR PROCESS ABNORMALITY. THE COMPLAINT OF CUFF LEAKAGE IS CONFIRMED AND WAS ATTRIBUTED TO A CUT ON THE TRACHEAL CUFF. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE UNINTENTIONAL USE ERROR.