MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR PROBE 15CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the liver ablation and the patient experienced abdominal wall pain/burn.They are currently surveying the patient for any further complications.Surgeon believed it could be tied to the angle that the probes were placed at within the patient that led to the post-op reaction.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/26/2024, b3: event year only reported: 2024, 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.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: please provide details about precise site of the burn.What is the relationship of the location site of the burn verses where the probes were being used? what was the severity of the burn? how was the burn/pain treated? was a re-operation required? can any photos be provided? what is the doctor's experience with the device? what¿s the patient¿s current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: 11/21/2024 additional information was requested and the following was obtained: in the response, it was mentioned the patient didn¿t need any ¿special treatment.¿ can you please provide what exact treatment the patient underwent to address the pain/burn? was the grade of the burn ever determined? "our plastics team gave topical care, but no surgery.Sorry, they never put a grading scale in their note" attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: can you please provide more details on the topical care? was the topical treatment prescribed or over the counter?.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/7/2024.Additional information was requested and the following was obtained: almost all better.He did not need any special treatment.Should be getting our 3 month scan very soon.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: in the response, it was mentioned the patient didn't need any ¿special treatment.¿ can you please provide what exact treatment the patient underwent to address the pain/burn? was the grade of the burn ever determined? call home did not reveal any issues or errors.No device will be returned to neuwave for further investigation.Potential cause unknown.A search of nonconformities (ncs) was performed for lot: ml24018857.There were no observed nonconformities for this lot.Manufacture date: 1/1/2024, expiration date: 9/30/2027.

• Brand Name: NEUWAVE PR PROBE 15CM 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 WI 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 20318045
• Report Number: 3008769756-2024-00022
• Device Sequence Number: 12682414
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: 00853719006395
• 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): 09/26/2024

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: PR15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 11/07/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/07/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown