MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR PROBE 20CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR20
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	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: at what point during the procedure was the burn identified? near the end.Did they have any device malfunction or deficiency prior, during, and after ablation? no.Error message, dr.Stated, "i know when it is not in tissue it will shut off." what was the location of the tumor within the liver? segment 3.How deep was the tumor? superficial.Are any pictures available of the burn? yes.Does the doctor believe 1 probe, both probes, and/or the system caused and/or contributed to the burn? unknown suspect one probe.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 a liver ablation procedure that it was noticed that the probes were burning the patient¿s skin.When attempting to ablate in another area one of the two probes would not come up to temp.Also, throughout the procedure the system would pop up an unknown purple icon at which time they would have to click continue to ablate.System would not ablate for the entire ten minutes at a time.Third degree burn was being excised and debrided.Patient doing fine.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/28/2022.Investigation summary call home revealed reflected power errors.The probe returned to neuwave and all functions worked to specifications.Vno issues/errors were seen.A search of nonconformities (ncs) was performed for lot ml22017382.There were no observed nonconformities for this lot.Medical safety officer photo analysis: three photos associated with this complaint are available for the evaluation.Photo 1 & 2 were taken for the ablation probe insertion site.A dark charred burn area is visualized surrounding the needle with peripheral skin appearing yellowish and some redness.The central area of superficial skin shows wrinkle but no break down observed.He burn injury appears to be third degree of burn at the central portion.The photo 3 was taken on screen display showing internal view of the burn injury.The affected area shows whitening and yellow color, indicating the burn injury has involved deep layer tissue of abdominal wall.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/7/2022 additional information was requested and the following was obtained: what was the location of the probe insertion? was the procedure done in conjunction with a laparoscopic procedure? probe location was in abdomen for lap liver microwave.Yes done in conjunction of a lap case.Yes procedure was during a laparoscopic procedure.The probes were placed in the patient in liver area.

• Brand Name: NEUWAVE PR PROBE 20CM 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 ; 6107428552
• MDR Report Key: 15715918
• Report Number: 3008769756-2022-00056
• Device Sequence Number: 11986200
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 853719006418
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/02/2022

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 Catalogue Number: PR20
• Device Lot Number: ML22017382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 11/23/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown