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

Model Number CS-2001

Device Problem Difficult to Insert (1316)

Patient Problem Laceration(s) of Esophagus (2398)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 322019801
• Report Number: 3009437315-2023-00003
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10860237000214
• UDI-Public: 10860237000214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization