MAUDE Adverse Event Report: CIRCA SCIENTIFIC, INC. MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE

Model Number	CS-31EP
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Minimal bleeding may have resulted from the tip separating leading to a sharp edge.No reason for tip separation could be concluded based on evidence of adhesive at the bond location, a review of testing per the dhr, and pull testing of similar product.
Event or Problem Description
Upon removal, there was blood, and the probe tip was missing.Additionally, the same probe reached a high temperature on one of the channels before the temperature bar disappeared.The same issue occurred with a second sensor.

• Brand Name: MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE
• Common Device Name: ESOPHAGEAL TEMPERATURE PROBE
• Manufacturer (Section D): CIRCA SCIENTIFIC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer (Section G): CIRCA SCIENTIFIC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; englewood, CO 80112 ; 3039518767
• MDR Report Key: 22905560
• Report Number: 3009437315-2025-00004
• Device Sequence Number: 21104498
• Product Code: FLL
• UDI-Device Identifier: 10851498007135
• UDI-Public: 10851498007135
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K222311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CS-31EP
• Device Lot Number: 14661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown