MAUDE Adverse Event Report: CIRCA SCIENTIFIC ESOPHAGEAL TEMPERATURE PROBE; NONE

Model Number CS -2001

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/30/2014

Event Type  Other  

Event Description

The prep tube was left on the temperature probe during probe insertion.Upon removal of the temperature probe and prep tube the instruction label was retained in the pharynx.Dates of use: (b)(6) 2015.Diagnosis or reason for use (indication): continuous temperature monitoring during an ablation.

• Brand Name: ESOPHAGEAL TEMPERATURE PROBE
• Type of Device: NONE
• Manufacturer (Section D): CIRCA SCIENTIFIC; englewood CO 80112
• MDR Report Key: 4604075
• MDR Text Key: 5630083
• Report Number: MW5041410
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS -2001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR