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

Model Number	LK15XT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: the doctor was unsure if the probe was the cause of the subcutaneous emphysema.When the surgeon pulled the probe back, was there any deficiency or damaged to the tip of the probe? how was the subcutaneous emphysema treated? in the physician¿s opinion was there any device defect or malfunction that caused or contributed to the subcutaneous emphysema? what is the patient's current status? no damage was seen to the probe.Physician sent home patient with the expectation it would resolve itself.He was unsure of the cause.Patient status currently unknown.Not enough information was received to perform a call home review.No device will be returned to neuwave for further investigation since it was discarded.The root cause is unknown.No lot information was provided therefore no lot history review could 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 an ablation procedure using a lk15xt probe, after the ablation was completed, on the ct, there was subcutaneous emphysema.It was not present on the preablation scan however it showed up on the 5 and 10 minute ablation scan.The procedure was completed and there was no complication known to the patient other than subcutaneous emphysema.

• Brand Name: NEUWAVE LK XT PROBE 15CM 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: 14698314
• Report Number: 3008769756-2022-00032
• Device Sequence Number: 20165319
• Product Code: NEY
• UDI-Device Identifier: 00853719006364
• UDI-Public: 00853719006364
• 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
• Report Date (Section B): 06/15/2022

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 Model Number: LK15XT
• Device Catalogue Number: LK15XT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown