SITUATE 01-0027

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for SITUATE 01-0027 manufactured by Mitg - Rf Surgical Systems.

Event Text Entries

[142878046] 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.
Patient Sequence No: 1, Text Type: N, H10


[142878047] According to the reporter, intra-operatively, the console was providing false readings.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005883396-2019-00024
MDR Report Key8524631
Date Received2019-04-17
Date of Report2019-04-17
Date of Event2018-08-08
Date Mfgr Received2019-04-01
Date Added to Maude2019-04-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1MITG - RF SURGICAL SYSTEMS
Manufacturer Street2101 FARADAY
Manufacturer CityCARLSBAD CA 92008
Manufacturer CountryUS
Manufacturer Postal Code92008
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSITUATE
Product CodeMMP
Date Received2019-04-17
Returned To Mfg2019-04-10
Model Number01-0027
Catalog Number01-0027
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMITG - RF SURGICAL SYSTEMS
Manufacturer Address2101 FARADAY CARLSBAD CA 92008 US 92008


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-17

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