MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL

Model Number 01-0031

Device Problem False Positive Result (1227)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2019

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 testing, the mat was not able to function correctly when the cord was running down the bed rail.Once the cord was layed on the floor everything worked correctly.If you run the cord down the rail on the bed, you will get a detection.This increases the signal and will detect sponged 10 feet away.There was no patient involved.

• Brand Name: SITUATE
• Type of Device: COUNTER, SPONGE, SURGICAL
• 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: 8430818
• MDR Text Key: 139182295
• Report Number: 3005883396-2019-00016
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-0031
• Device Catalogue Number: 01-0031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1