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 Date 01/26/2022

Event Type  Injury  

Event Description

Physician reported that they encountered resistance upon insertion into the esophagus.They tried multiple times to insert probe and met resistance.An injury appeared to have occurred evidency by bleeding.Reports patient was doing well on the following day.

Manufacturer Narrative

Probe was discarded by the hospital after use and therefore no visual inspection of the complaint probe could be performed.Performed a review of the device history records, labeling and evaluation of a probe from released stock.Based on evaluation of sample from released stock and engineering change review, there is no product change or defect that would attribute to the esophageal bleeding.Hospital communicated that the situation was likely due to irregular anatomy of patient's esophagus and difficult insertion of 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 SCIENTIFC, INC.; 14 inverness drive east; suite h-136; englewood CO 80112
• Manufacturer Contact: fred piazza ; 14 inverness drive east; suite h-136; 3039518767
• MDR Report Key: 13595602
• MDR Text Key: 287547289
• Report Number: 3009437315-2022-00001
• Device Sequence Number: 1
• Product Code: FLL
• 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: 02/24/2022

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
• Device Operator: Health Professional
• Device Model Number: CS-2001
• Device Lot Number: 17394-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization