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

Catalog Number	PR15XT
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/3/2023.B3: event day and year were only reported.D4 batch #: unknown.Investigation summary.Call home revealed multiple reflected power errors.The returned probe looked normal but failed test with reflected power.The probe was tested again and passed.An ablation was started and after a few seconds, there was an arc at the probe tip which caused the probe to bend.After visual inspection, the probe tip was bent.The probe was disconnected and there was evidence of thermal damage.The potential cause of the damage is unknown due to the high amount of thermal damage.A search of nonconformities (ncs) was performed for lot ml23048161.There were no observed nonconformities for this lot.Manufacture date: 4/1/2023.Expiration date: 12/31/2026.
Event or Problem Description
It was reported that during the left adrenal ablations procedure that while using up to three probes.One probe stopped working and would not allow them to retest.The problem with the probe did not cause any damage to patient.

• 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: 18064420
• Report Number: 3008769756-2023-00038
• Device Sequence Number: 15335358
• 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
• Report Date (Section B): 11/03/2023

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: ML23048161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown