MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR PROBE 15CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR15
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/4/2025.D4 batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: was the pneumothorax in need of any treatment? if so, what was treatment? in physician¿s opinion, how was the device related to the pneumothorax? how did the device cause or contribute to the pneumothorax? when the device was removed, was there any probe tip damage? when the device was removed, was the probe tip broken off? what is the current patient¿s status? the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 during a lung ablation procedure the device stopped working after approximately 90 seconds of ablation and ceased functioning on its own.A small pneumothorax occurred during removal of the probe.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/19/2025.D4 batch #: unknown.Corrected data: b1, b2, h6 medical device problem code.Additional information was requested and the following was obtained: was the pneumothorax in need of any treatment? yes.If so, what was treatment? chest tube.In physician¿s opinion, how was the device related to the pneumothorax? how did the device cause or contribute to the pneumothorax? since the device stopped working, and needed to be removed from the pleura, it caused unnecessary crossing of the pleura which put the patient at higher risk for a ptx.When the device was removed, was there any probe tip damage? not sure.When the device was removed, was the probe tip broken off? no.Investigation summary: call home revealed reflected power errors.The returned probe did not display any damage.All functions worked to specifications.The potential cause of the reflected power errors and pneumothorax is unknown.A search of nonconformities (ncs) was performed for lot ml24109599.There were no observed nonconformities for this lot.

• Brand Name: NEUWAVE PR PROBE 15CM 17GA
• 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: 23464895
• Report Number: 3008769756-2025-00015
• Device Sequence Number: 15940232
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: (01)00853719006395(17)280630(10)ML24109599
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PR15
• Device Lot Number: ML24109599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown