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

Model Number	G0404-16P01CN-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not sold in us and is 510(k) exempt.Evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned but a photo was provided.Visual inspection of the photo noted that the gauzes were removed from the package.Linting was noticed in the pictures and gauzes appear to be manipulated.It was reported that the product was linting.An associated device issue was confirmed based on the photo.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the gauze sponges are made with natural cotton and may produce lint or fibers when unfolded or manipulated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had poor quality of gauze.Little strings pulled out of the patient.A photo submitted showed a tiny piece of strand coming from the gauze.There was no patient injury.

• 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: 10245008
• Report Number: 3005883396-2020-00032
• Device Sequence Number: 3194716
• Product Code: GDY
• UDI-Device Identifier: 10884521700819
• UDI-Public: 10884521700819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: G0404-16P01CN-1
• Device Catalogue Number: G0404-16P01CN-1
• Device Lot Number: 200109AT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1