MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE

Model Number 01-0049

Device Problem False Negative Result (1225)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, they had a miscount, but the system did not detect the raytec, they took an x-ray and found the raytec.They then tested the wand and console with another piece of cotton and it detected it.No patient injury.

• Brand Name: SITUATE
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer (Section G): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8523361
• MDR Text Key: 146371053
• Report Number: 3005883396-2019-00023
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-0049
• Device Catalogue Number: 01-0049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• 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
• Patient Outcome(s): Required Intervention