MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE SR PROBE 25CM 13GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	NWSR25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 8/19/2025 d4 batch #: unknown.Additional information was requested and the following was obtained: what is the severity of the burn? (please see degrees of burns below and choose one) - at the center, there is a <5 mm area of full thickness burn and surrounded by a 10x15mm area of second-degree burn.What medical intervention was used to treat the burn? (such as salve or stitches) - wound care with silvadene and topical abx.Besides the burn, did the patient experience any adverse consequence due to the issue? no other issues related to this.Are there any anticipated long-term effects from the burn or injury? - just scarring i believe.Hopefully, there should not be other long-term effects.Was the ablation laparoscopic or percutaneous? laparoscopic.Where was the location of the tumor in the liver? there were multiple left sided and right sided lesions, in all segments except segment 1.What was the insertion approach? there were two skin insertion sites for the probe, one in the left subcostal area and one in right subcostal.What was the depth of the probe shaft into the body? since we were laparoscopic, all lesions were at least 10cm away from the abdominal wall.Depth subsequently varied depending on their segment locations.Is a photo of the burn injury available for review? attached is an image of the burn injury the physician proved me for your review what is the patient¿s current status? i'm seeing her in office soon.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.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 that during a liver ablation procedure the device caused skin burn to the patient.
Additional Manufacturer Narrative
(b)(4) date sent: 9/17/2025.The attached photo of the patient was reviewed by the medical safety officer: "the photo shows bright red, slightly wrinkled skin around the right ablation probe entry site, possibly caused by thermal burns.Two other tiny incisions are also visible, one of which is slightly bleeding." investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the nwsr25 device was returned with no apparent damage.Call home was reviewed for system nm22nea0173 on 07/28/2025.There was no call home data within 3 weeks of the provided case date.No call home data was available.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 ml24059159.There were no observed nonconformities for this lot.Manufacture date: 05/01/2024 expiration date: 01/31/2028.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/25/2025.Corrected data: h6 and h11.The attached photo of the patient was reviewed by the medical safety officer: "the photo shows bright red, slightly wrinkled skin around the right ablation probe entry site, possibly caused by thermal burns.Two other tiny incisions are also visible, one of which is slightly bleeding.".Investigation summary: the call home data revealed lower than expected ablation temperatures in some deliveries.A couple factors may have attributed to these lower temperatures.Sr probes tend to ablate at lower temperatures than others, and the active zone of the probe may have been near the skin's surface, in which case the temperature displayed would be lower.However, the additional information stated the probe's insertion depth was 10cm, therefore the active zone was not close to the skin's surface.The product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the nwsr25 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.Microwave ablations best practices are to ensure the radiating section of the probe is always fully inserted into tissue to prevent elongated waveform fields that can cause unintended thermal energy delivery to the user or patient.The characteristics of microwave fields differ based on the permittivity of the local environment around the radiating section of the probe.As part of neuwave medical quality process all devices are manufactured, inspected, and released to approved specifications.A search of nonconformities (ncs) was performed for lot ml24059159.There were no observed nonconformities for this lot.

• Brand Name: NEUWAVE SR PROBE 25CM 13GA
• 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: 22840927
• Report Number: 3008769756-2025-00012
• Device Sequence Number: 4822855
• Product Code: NEY
• UDI-Device Identifier: 00853719006432
• UDI-Public: (01)00853719006432(17)280131(10)ML24059159
• 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,Followup,Followup
• Report Date (Section B): 08/19/2025

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: NWSR25
• Device Lot Number: ML24059159
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 09/24/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/17/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: Required Intervention
• Patient Sex: Unknown