MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR PROBE 20CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of probe broke in cirrhotic liver post ablation.Patient was sent to surgery to remove fragments.No delay was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/9/2025.D4 batch #: unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: what was the insertion approach for the ablation procedure? percutaneous.Was a lateral force applied to the probe at any point during the procedure? no.Did the probe require extra force during insertion? no.Did the physician experience any resistance during insertion and/or use? yes, liver was very cirrhotic.Were there any probe complications/was the probe working normal during the ablation procedure? yes, but received error when attempting cauterization.When the probe was removed, was any angulation applied? no.When did they notice the tip was broken off post ablation? yes.When was the patient sent to surgery to remove the fragments after the broken probe tip was discovered? yes.Is call home data available? yes.Can the device be returned for analysis? yes.What is the patient¿s current status? fragments were removed and patient recovered from last conversation with physician.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/18/2026.Corrected data: d4 udi #.Investigation summary: call home did not reveal and issues or errors until the end of the case, when a probe temperature measurement error issues.This can usually indicate the user breaking the cannula to dispose.The returned device's cannula was broken off at the 9cm mark from the tip-the remainder (tip end) adjacent to the tip was not included.The potential cause of the broken cannula is unknown.Since the portion of the broken cannula containing the tip was not included with the return, a probe tip break cannot be verified.A search of nonconformities (ncs) was performed for lot ml22027420.There were no observed nonconformities for this lot.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/23/2026.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.

• Brand Name: NEUWAVE PR PROBE 20CM 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: 23255375
• Report Number: 3008769756-2025-00014
• Device Sequence Number: 21395287
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: (01)00853719006418(17)251031(10)ML22027420
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: PR20
• Device Lot Number: ML22027420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 02/13/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 01/23/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male