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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a liver microwave ablation that the ablation temperature is constantly around 92 degree c (s7, 2.5 cm lesion) for the first cycle 7 minutes.The ablation zone is not large enough as expected which below 100 degree c, thus he has to add another cycle 2:50mins.No parts of the instrument left inside patient's cavity.The procedure was delayed 2:50mins but completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4) date sent: 12/11/2024 b3: event year only reported: 2024 d4 batch #: unknown.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/7/2025.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/24/2025 investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Since this complaint occurred in hong kong, there is no call home data available.Visual analysis of the returned sample determined that the pr15xt device was returned with no apparent damage.Functional testing was conducted on the returned device and all features (test, tissu-loc, ablate) worked to specifications.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.A search of nonconformities (ncs) was performed for lot ml24069250.There were no observed nonconformities for this lot.Manufacture date: 06/01/2024 expiration date: 02/28/2028.

• 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 WI 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 20905892
• Report Number: 3008769756-2024-00040
• Device Sequence Number: 13056622
• Product Code: NEY
• UDI-Device Identifier: 00853719006401
• UDI-Public: (01)00853719006401(17)280229(10)ML24069250
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2024

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: ML24069250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 02/24/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/07/2025; 02/24/2025
• 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