MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE
Received Mar 28, 2025 · Event occurred Mar 3, 2025
Report 3009437315-2025-00001 · MDR key 21724964
Device
Generic name
Esophageal Temperature Probe
Manufacturer
Circa Scientific, Inc.Model number
CS-31EPLot number
14659
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
THE RETURNED MATRIX12 M PROBE MET DIMENSIONAL SPECIFICATIONS AND NO DEFECTS OBSERVED THAT WOULD CAUSE DIFFICULT PLACEMENT. ROOT CAUSE IS INDETERMINATE, IT IS NOT KNOWN WHY USER EXPERIENCED DIFFICULT PLACEMENT.
Description of Event or Problem
ANESTHESIA STATED DIFFICULT PLACEMENT WITH MATRIX12 M PROBE. PROBE THOUGHT TO BE IN ESOPHAGUS, DEPLOYED AND PLACEMENT FOUND TO BE IN BRONCHIAL STEM. BLEEDING OCCURRED. NOTHING UNUSUAL ABOUT ANATOMY ACCORDING TO ANESTHESIA & STAFF. THE LAB ALSO STOCKS S-CATH M. THIS WAS USED AFTER MATRIX12 M WAS REMOVED. THEY EXTUBATED SUCCESSFULLY AFTER THE CASE WAS FINISHED USING S-CATH M.