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

Catalog Number	PR15XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 8/20/2025.D4 batch#: unknown.Additional information was requested and the following was obtained: was the probe tip broken inside or outside of the body? as per the radiologist, an artifact was noticed on the post-imaging after the probe was removed.If inside the body, was the probe tip removed? the tip was not removed.What is the approximate size of the broken piece?.It would be estimated to be ½ inch.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: what was the spacing (in length) between the 2 probe tips during the ablation? what were the power settings for each probe during the procedure? are there any plans for retrieving the broken probe tip from the patient? what is the patient¿s current 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 is pending for the finished device lot number.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 during an ablation procedure the tip of the probe broke off.He was not operating under a bone or anything similar.There were no patient adverse event.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/8/2025.Investigation summary.Call home revealed a probe temperature too high error on the probe that was not returned, as well as reflected power errors from the returned probe.The probe returned to neuwave.The probe's tip was broken off near the ceramic and not included with the return kit.According to the additional information, the tip remained inside the patient after the event.The returned piece displayed evidence of thermal damage, including charring and a blackened area around the broken edge.The potential cause of the tip break is unknown due to the amount of thermal damage seen.A search of nonconformities (ncs) was performed for lot.There were no observed nonconformities for this lot.

• Brand Name: NEUWAVE PR XT PROBE 15CM 15GA
• 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: 22852317
• Report Number: 3008769756-2025-00013
• Device Sequence Number: 14557657
• Product Code: NEY
• UDI-Device Identifier: 00853719006401
• UDI-Public: (01)00853719006401(17)280630(10)ML24109640
• 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): 08/20/2025

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: PR15XT
• Device Lot Number: ML24109640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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
• Patient Sex: Unknown