LEVEL 1 MYOCARDIAL TEMPERATURE SENSORS
Received Jan 30, 2026 · Event occurred Nov 25, 2025
Report 3012307300-2026-00748 · MDR key 24223183
Device
Generic name
Thermometer, Electronic, Clinical
Catalog number
MTS-40015
Lot number
6097014
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THERE WERE NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MYOCARDIAL TEMPERATURE SENSOR. DURING REMOVAL OF THE TEMPERATURE PROBE FROM THE TISSUE, THE METAL PORTION BROKE OFF AND REMAINED IN THE TISSUE. AN X-RAY WAS PERFORMED AFTER RETRIEVAL TO CONFIRM COMPLETE REMOVAL OF THE METAL FRAGMENT. THE ISSUE WAS RESOLVED.