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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 01-0046
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/09/2019
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, during the insertion of tandem and ovoids, the vaginal packing was not detected by the wand, but it was present.The team knew that the vaginal packing was intentionally retained and scanned the patient with the wand and still no detection made.Patient left the or and went to radiology.Packing was later removed.There was no patient injury.
 
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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 Key8294833
Report Number3005883396-2019-00006
Device Sequence Number1620022
Product Code LWH
UDI-Device Identifier10884521700727
UDI-Public10884521700727
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/31/2019
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 Number01-0046
Device Catalogue Number01-0046
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/09/2019
Initial Report FDA Received Date01/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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