MAUDE Adverse Event Report: CIRCA SCIENTIFIC, INC. S-CATH ESOPHAGEAL TEMPERATURE PROBE

Model Number	CS-2001
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No alleged defect with probe or instructions.Probe was discarded by the hospital after use, and therefore no visual inspection of the complaint probe could be performed.Event may have occurred due to user not following instructions and placing probe despite resistance being felt during device introduction.
Event or Problem Description
A patient had a perforation in their throat and they think it may be from when the crna introduced the probe.

• Brand Name: S-CATH 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: 17627653
• Report Number: 3009437315-2023-00003
• Device Sequence Number: 20363146
• Product Code: FLL
• UDI-Device Identifier: 10860237000214
• UDI-Public: 10860237000214
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K112376
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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-2001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Unknown