COPILOT

Description of Event or Problem

IT WAS REPORTED THAT THE SIDE PORT OF THE CO-PILOT DID NOT THREAD [CONNECT]. A NEW CO-PILOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A PRODUCTION RECORD REVIEW AND A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBER WAS NOT REPORTED. IT IS POSSIBLE THAT THE DEVICES WERE NOT PROPERLY ALIGNED AND/OR NOT FULLY CONNECTED/TIGHTENED WHILE ATTEMPTING TO CONNECT AND/OR THE PORT OF THE DEVICE BEING CONNECTED WAS COMPROMISED RESULTING IN THE REPORTED LOOSE/INTERMITTENT CONNECTION; HOWEVER, AS HE DEVICE WAS NOT RETURNED THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.