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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL
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MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL Back to Search Results
Model Number 01-0043R
Medical Device Problem Codes False Positive Result (1227); Failure to Power Up (1476); Intermittent Energy Output (4025)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/15/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, prior to use, the unit shut often.It also give wrong reading when they scanned it.There was no patient involvement.
 
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SITUATE
Common Device Name
COUNTER, SPONGE, SURGICAL
Manufacturer (Section D)
MITG - RF SURGICAL SYSTEMS
2101 faraday
carlsbad CA 92008
MDR Report Key7659082
Report Number3005883396-2018-00058
Device Sequence Number11391773
Product Code LWH
UDI-Device Identifier10884521705319
UDI-Public10884521705319
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number01-0043R
Device Catalogue Number01-0043R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Initial Date Received by Manufacturer 06/18/2018
Supplement Date Received by Manufacturer08/01/2018
Initial Report FDA Received Date07/03/2018
Supplement Report FDA Received Date08/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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