InjuryFLL
MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE
Received May 22, 2025 · Event occurred Apr 18, 2025
Report 3009437315-2025-00002 · MDR key 22071935
Device
Generic name
Esophageal Temperature Probe
Manufacturer
Circa Scientific, Inc.Model number
CS-31EPLot number
14660
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
NO TESTING COULD BE PERFORMED AS PROBE WAS NOT RETURNED. BASED ON SIMILAR COMPLAINT TESTING, THERE IS NO KNOWN DEFECT THAT WOULD PREVENT PROPER PLACEMENT. ROOT CAUSE IS USER DID NOT APPEAR TO FOLLOW INSTRUCTIONS FOR USE AND VERIFY PROPER PLACEMENT WITH FLUOROSCOPY OR 3D MAPPING SYSTEM.
Description of Event or Problem
ANESTHESIOLOGIST BELIEVED THAT PROBE WAS PLACED IN THE BRONCHUS AND BLEEDING OCCURRED UPON REMOVAL. PATIENT HAD TO REMAIN INTUBATED, HAD A BRONCH DONE AND WAS EXTUBATED ON MONDAY (B)(6).