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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 G0804-12P02C-1
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/20/2021
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 a robotic vaginoplasty procedure, the resident placed raytec device into the trocar and started to advance it down into the abdomen.It was noted as they began that the tracker from the raytec had fallen on to the drapes.Action of advancement was discontinued immediately.Tracker was removed from the field.No blood transfusion was necessary.There was no patient injury.
 
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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 Key12086256
Report Number3005883396-2021-00017
Device Sequence Number4359072
Product Code GDY
UDI-Device Identifier10884521700833
UDI-Public10884521700833
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (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) 06/29/2021
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 Expiration Date09/12/2025
Device Model NumberG0804-12P02C-1
Device Catalogue NumberG0804-12P02C-1
Device Lot Number201014AT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/08/2021
Initial Report FDA Received Date06/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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