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

Model Number	LK15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: where was the location of the tumor? segment 2.How shallow or deep was the tumor in relation to the surface of the skin? the metastatic lesion measured 3.8 cm.The lesion was centrally located in segment 2 of the liver.The physician pushed air, in the attempt to act as a buffer between the liver capsule and body wall before ablation was performed.Please confirm/what do they mean ¿they knew that they were getting closer to the skin¿? does this mean the tip shallow? the first scan was taken after 2 minutes of ablation to evaluate.At this point the probes were located in the location desired by the physician.The physician started the ablation again and wanted to scan at 5 mins to evaluate.During this scan, is where the probes were identified to have migrated and the ablation was aborted.How was the burn treated? wound vac was applied.What is the patient's current condition? patient was released from the hospital (b)(6) 2021.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of neuwave's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.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 a liver ablation, the patient experienced a skin burn.The burn was between a dime to the size of a nickel.The middle of the burn was a white and then on the outside it was a pink reddish color.It was planned to be a ten minute burn.They scanned intermittently every two minutes.They ended up seeing subcutaneous fat leakage.They knew that they were getting closer to the skin.They shut off the unit at five minutes in.They did not complete the ten minute burn.At the time of the call patient outcome was unknown.
Additional Manufacturer Narrative
(b)(4).Call home did not reveal any issues or errors.No device will be returned to neuwave for further investigation since it was discarded.Root cause unknown.

• Brand Name: NEUWAVE LK PROBE 15CM 17GA
• 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: kara ditty-bovard ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 12778533
• Report Number: 3008769756-2021-00096
• Device Sequence Number: 17015534
• Product Code: NEY
• UDI-Device Identifier: 00853719006357
• UDI-Public: 00853719006357
• 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
• Report Date (Section B): 11/09/2021

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: LK15
• Device Catalogue Number: LK15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/10/2021
• 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