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

Catalog Number	PR15XT
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation they had a patient incident with a probe tip breaking off inside the patient.Burned for 4 to 4.5 minutes.Temperature jumped up significantly and then stopped, reflected power error.They tried to turn it on again and it burned for a second before they realized the tip burned off.No patient consequence since the probe tip was retrieved.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/22/2023.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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: 11/21/2023.Investigation summary: call home revealed reflected power errors after 4:16.The probe was returned to neuwave.The probe's tip was broken off but returned with the device.The probe was disassembled and there were signs of thermal damage leading to the ceramic fracture.The potential cause of the tip break is unknown due to the amount of thermal damage seen.A search of nonconformities (ncs) was performed for lot ml23058259.There were no observed nonconformities for this lot.Manufacture date: 5/1/2023 expiration date: 1/31/2027.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/25/2023.

• 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: 17803128
• Report Number: 3008769756-2023-00034
• Device Sequence Number: 15298643
• Product Code: NEY
• UDI-Device Identifier: 00853719006401
• UDI-Public: 853719006401
• 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): 09/22/2023

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 Catalogue Number: PR15XT
• Device Lot Number: ML23058259
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/04/2023; 11/17/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/25/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown