MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS MICROTHERMX MICROWAVE ABLATION SYSTEM; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	SWST-1415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After review of the data retrieved from the system, it is confirmed that there was a disconnection of the antenna circuit (i.E., tip separation).The cause of the tip separation cannot be confirmed as the device has not been returned for evaluation.
Event or Problem Description
Varian representative reported "tip of the microwave antenna broke off in the patient after the 2nd burn was complete.Doctor did not feel any resistance.Noticed it was broken after removal." the treatment was completed.The event occurred during liver ablation.As of (b)(6) 2021: patient status is stable.The tip has not been recovered from the patient.No further intervention is planned at this time.The customer has refused to provide additional information beyond patient status at this time.

• Brand Name: MICROTHERMX MICROWAVE ABLATION SYSTEM
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 9825 spectrum dr; bldg. 2; austin TX 78717
• MDR Report Key: 11814183
• Report Number: 3008262715-2021-00001
• Device Sequence Number: 19774690
• Product Code: NEY
• UDI-Device Identifier: 00810563020571
• UDI-Public: 00810563020571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: SWST-1415
• Device Catalogue Number: SWST-1415
• Device Lot Number: 315D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR