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

Catalog Number	PR20XT
Medical Device Problem Codes	Break (1069); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open distal pancreatectomy with splenectomy, ultrasound, open cholecystectomy, diaphragm resection, partial left adrenalectomy, left lateral sectionectomy, and microwave ablation of the liver the probe got too hot and the tip broke off in the liver.The tip was retrieved from the patient and the patient is doing fine.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/20/2026.D4 batch #: unknown.Investigation summary : call home revealed reflected power errors and probe temperature too high error occurred on a non-ablating probe (it is possible the ablating other probe was close to the probe).No device will be returned to neuwave for further investigation.The potential cause is unknown.A search of nonconformities (ncs) was performed for lot ml25120222.There were no observed nonconformities for this lot.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.

• 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: 24927379
• Report Number: 3008769756-2026-00003
• Device Sequence Number: 10668540
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: (01)00853719006425(17)290831(10)ML25120222
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: PR20XT
• Device Lot Number: ML25120222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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