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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/20/2024.D4 batch #: unknown.Investigation summary: no call home data could be found for this system within the given date range.The returned probe had zero uses.The tip was broken but still connected.The break was mechanical in nature.The information provided explained the probe tip was broken prior to introduction in the patient.The potential cause is user handling.A search of nonconformities (ncs) was performed for lot ml23078420.There were no observed nonconformities for this lot.Manufacture date: 7/1/2023.Expiration date: 3/31/2027.
Event or Problem Description
It was reported that during a liver ablation procedure that prior to introduction into the patient the tip of the probe broke but did not did not detach.Another like device was used to continue with the procedure.There were no adverse consequences for the patient.

• 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: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 20029563
• Report Number: 3008769756-2024-00018
• Device Sequence Number: 12911729
• Product Code: NEY
• UDI-Device Identifier: 00853719006401
• UDI-Public: (01)00853719006401(17)270331(10)ML23078420
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: PR15XT
• Device Lot Number: ML23078420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown