MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	PR20XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that during the liver ablation procedure, the probe was working properly in the liver and they were doing a ten minute ablation and half way through, the ablation stopped and when they removed the probe, the tip of the probe was broken.So they had to remove the probe and place a new probe.The procedure was completed with no patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/28/2022.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/18/2022.Investigation summary: no call home data could be found for this system in the given date range.Probe jj21nhc53727 (6 uses, 33:31) was investigated at neuwave.The probe had a broken tip and charring.No further information was available.The root cause of the damage is unknown.There is no lot information available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.A search of nonconformities (ncs) was performed for lot: ml21117142.There were no observed nonconformities for this lot.

• Brand Name: NEUWAVE PR XT PROBE 20CM 15GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: orla o'mahony ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 14643151
• Report Number: 3008769756-2022-00031
• Device Sequence Number: 12185838
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 853719006425
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/09/2022

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 Model Number: PR20XT
• Device Catalogue Number: PR20XT
• Device Lot Number: ML21117142
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 07/13/2022; 12/21/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 06/28/2022; 07/18/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown