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

Catalog Number	PR15
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	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/13/2023.D4 batch #: unknown.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.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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 the liver ablation procedure that the doctor reported that the ablations zone was smaller than usual.They had to do a couple of additional burns to get proper ablation zone.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/15/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Call home revealed one reflected power error.All temperatures looked normal during the ablations.Upon visual inspection, it was noted that the tip was slightly bent and had charred tissue on it.Because of the returned device condition, no functional test could be performed.No conclusion could be reached as to what caused this issue.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: ml22067863.There were no observed nonconformities for this lot.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/9/2023.

• 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 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 17317250
• Report Number: 3008769756-2023-00025
• Device Sequence Number: 11779780
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: 853719006395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2023

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 Expiration Date: 02/28/2026
• Device Catalogue Number: PR15
• Device Lot Number: ML22067863
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 08/11/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/09/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown