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)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 13595998
• Report Number: 3009437315-2022-00002
• Device Sequence Number: 14915022
• Product Code: FLL
• UDI-Device Identifier: 10860237000214
• UDI-Public: 10860237000214
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2024
• Device Model Number: CS-2001
• Device Lot Number: 17394-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESOSURE ESOPHAGEAL RETRACTOROG TUBE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown