MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	G0404-32P01C-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during procedure, radiofrequency identification (rfid) came out of its pocket and was retained in the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 procedure, radiofrequency identification (rfid) came out of its pocket and was retained in the patient.

• Brand Name: SITUATE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer (Section G): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13577000
• Report Number: 3005883396-2022-00004
• Device Sequence Number: 14837615
• Product Code: GDY
• UDI-Device Identifier: 10884521700819
• UDI-Public: 10884521700819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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 Expiration Date: 04/09/2026
• Device Model Number: G0404-32P01C-1
• Device Catalogue Number: G0404-32P01C-1
• Device Lot Number: 210601AT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown