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

Model Number	L0418-04P01CN-1
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2019
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 breast tissue dissection, the product component was shredding.Shredding components were retrieved.

• 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: 8799206
• Report Number: 3005883396-2019-00050
• Device Sequence Number: 19454057
• Product Code: GDY
• UDI-Device Identifier: 20884521706870
• UDI-Public: 20884521706870
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: L0418-04P01CN-1
• Device Catalogue Number: L0418-04P01CN-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1