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  

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 bleeding.Hospital communicated egd was unrevealing with no clear source of bleeding, most likely oropharyngeal injury with blood into esophagus.Esosure esophageal retractor with an og tube was also used during the procedure.

Event Description

During probe insertion they encountered resistance.Doctor also uses esosure with an og tube.Og tube was inserted before circa probe.Toward end of case bleeding was noted.Ent was called and didn't note any damage.

• 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: 13595998
• MDR Text Key: 287547362
• Report Number: 3009437315-2022-00002
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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
• Date Manufacturer Received: 01/27/2022
• 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
• Treatment: ESOSURE ESOPHAGEAL RETRACTOROG TUBE
• Patient Outcome(s): Hospitalization