CORE DYNAMICS

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE THAT THE CORE TRUMPET FOR SINGLE OR DUAL SOLUTION BAG, DEVICE WAS BEING USED ON (B)(6) 2026 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THE CLINICIAN WAS SUCTIONING FLUID, AND THE WHITE VALVE WAS STICKING IN THE OPEN POSITION AND THEREFORE SUCTION CONTINUED. THIS CAUSED SOME NEAR MISSES THROUGHOUT THE PROCEDURE WHEN NEAR TO CLIPS AND POSSIBLE BRUISING TO THE BOWEL. THE SUCTION WAS TURNED DOWN BUT THE STICKING OF THE VALUE A LACERATION TO THE BOWEL OCCURRED AS THE BOWEL WAS SUCKED INTO THE END OF THE DEVICE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE IS A CORRECTION TO THE INJURY TO THE PATIENT THIS WAS ACTUALLY A SUPERFICIAL LIVER INJURY. FLOSEAL WAS APPLIED TO THE SUPERFICIAL LIVER INJURY. THE PROCEDURE WAS COMPLETED AND THERE WAS NO EXTENDED STAY FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "WELL IN RECOVERY". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF THE PATIENT OBTAINING A SUPERFICIAL LIVER INJURY.