inforMED
InjuryFLL

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

Model number

CS-31EP

Lot 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.