FDA Adverse Event
Injury
Summary report: N
S-CATH ESOPHAGEAL TEMPERATURE PROBE
MDR report key: 14311657
·
Received May 6, 2022
Report
- Report Number
- 3009437315-2022-00005
- Event Type
- Injury
- Date Received
- May 6, 2022
- Date of Event
- April 1, 2022
- Report Date
- May 5, 2022
- Manufacturer
- CIRCA SCIENTIFIC, INC.
- Product Code
- FLL
- UDI-DI
- 10860237000214
- PMA / PMN Number
- K112376
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PROBE WAS MISPLACED IN BRONCHUS RATHER THAN ESOPHAGUS. THERE IS NO DEFECT OR MALFUNCTION OF THE DEVICE. USER ERROR - FLUOROSCOPY WAS NOT USED DURING PROBE PLACEMENT. DEVICE IFU STATES TO USE FLUOROSCOPY DURING PROBE PLACEMENT.
Description of Event or Problem · 0
DR. REPORTS A PATIENT LUNG PERFORATION CAUSED BY CIRCA PROBE. PATIENT COUGHED UP BLOOD FOR FIVE DAYS, THEN RECOVERED. NO FLUOROSCOPY WAS USED IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1098788 | S-CATH ESOPHAGEAL TEMPERATURE PROBE | ESOPHAGEAL TEMPERATURE PROBE | FLL | CIRCA SCIENTIFIC, INC. | CS-2001 | 10860237000214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |