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

Model Number	VPK-0272C-R
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the rf tag of the device was missing.The device was not used in the procedure.No patient involved.

• 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 Key: 7138219
• Report Number: 3005883396-2017-05117
• Device Sequence Number: 16466270
• Product Code: GDY
• UDI-Device Identifier: 10884521701199
• UDI-Public: 10884521701199
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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 Number: VPK-0272C-R
• Device Catalogue Number: VPK-0272C-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1