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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE
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MITG - RF SURGICAL SYSTEMS SITUATE Back to Search Results
Model Number 01-0027
Device Problem False Negative Result (1225)
Patient Problem No Information (3190)
Event Date 08/08/2018
Event Type  malfunction  
Manufacturer Narrative
One device was received for evaluation.The returned sample met specification as received.The visual inspection found no notable conditions.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intra-operatively, the console was providing false readings.
 
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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 Key8524631
MDR Text Key142878046
Report Number3005883396-2019-00024
Device Sequence Number1
Product Code MMP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
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 Received04/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number01-0027
Device Catalogue Number01-0027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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