MAUDE Adverse Event Report: NeuWave Medical, Inc NeuWave; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	NWC1US1N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: NeuWave
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NeuWave Medical, Inc; 3529 anderson street; madison WI 53704
• Manufacturer Contact: katie inman ; 3529 anderson st; madison, WI 53704 ; +1(877)323-9283
• MDR Report Key: 50177146
• Report Number: 3008769756-2026-00012
• Device Sequence Number: 12832441
• Product Code: NEY
• UDI-Device Identifier: 00853719006753
• UDI-Public: (01)00853719006753(11)240930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K231738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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 Catalogue Number: NWC1US1N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown