MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR20XT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation the needle connected 1 time: error message, then reconnected: ok.Test: ok.Implantation in patient - stick: ok; then no functional treatment protocol.Needle reconnected to another channel: still not operational.Change for a new needle.No patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/14/2025.D4 batch #: unknown.Investigation summary: since this occurred in france, there is no call home data available.The returned probe's tip was broken off from the cannula.The break looks mechanical in nature.There does not seem to be any thermal damage.The potential cause of the broken probe tip is unknown since there is no further information available.A search of nonconformities (ncs) was performed for lot ml24069306.There were no observed nonconformities for this lot.Manufacture date: 06/01/2024.Expiration date: 02/28/2028.

• Brand Name: NEUWAVE PR XT PROBE 20CM 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 ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22021558
• Report Number: 3008769756-2025-00009
• Device Sequence Number: 8823791
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: (01)00853719006425(17)280228(10)ML24069306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: ML24069306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown