MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/9/2026.D4 batch #: unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported, that while in an ablation procedure, when pulling out the probe it had broken during the procedure inside the patient.The probe was removed in full, no pieces left behind.The ablation was completed prior to break, but during cautery it malfunctioned and that is where the break is suspected to have happened.Post ablation ct scan showed gas in the patient's abdomen.Probe was not kept for return due to patient be hep b positive.

• Brand Name: NEUWAVE
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison WI 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: orla o'mahony ; 3529 anderson st; madison 53704 ; 3035526892
• MDR Report Key: 25444563
• Report Number: 3008769756-2026-00006
• Device Sequence Number: 14884911
• Product Code: GEI
• UDI-Device Identifier: 00853719006395
• UDI-Public: (01)00853719006395(17)290331(10)ML25070039
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200081
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Catalogue Number: PR15
• Device Lot Number: ML25070039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown