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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
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MITG - RF SURGICAL SYSTEMS SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number G0804-16P02C-1
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
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 a total hip surgery, the doctor placed the item in the femoral canal, when it was removed, he dropped it into the kick bucket.The circulator opened the item and found that the rf device that is supposed to be imbedded on it was damaged and part of it was missing.They washed out the femoral canal thoroughly.The part that was missing is the plastic tip off of one end.There was no x-ray done.The doctor stated that it was unresolvable and washing out is the best they can do.
 
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Brand Name
SITUATE
Common Device Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Manufacturer (Section D)
MITG - RF SURGICAL SYSTEMS
2101 faraday
carlsbad CA 92008
MDR Report Key8749443
Report Number3005883396-2019-00037
Device Sequence Number11185096
Product Code GDY
UDI-Device Identifier20884521700854
UDI-Public20884521700854
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberG0804-16P02C-1
Device Catalogue NumberG0804-16P02C-1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2019
Initial Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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