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

Model Number	PR15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a liver resection procedure the tip broke off of the probe.Unknown if the fragment was retrieved.Another like device was used to complete the procedure.Surface of specimen was examined but not fragment was found.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2022.Batch #: unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2022 call home revealed a reflected power error and normal temperatures.Call home was reviewed for system (b)(6) on 3/9/22.This was a surgical liver case.Two pr15s, (b)(6)and (b)(6)2 were connected to channels 3 and 2 respectively.Probe 3 issued two reflected power errors on test, then was disconnected and moved to channel 1.Probes 1 and 2 were tested and ablated for 9:07 (probe 1, 141c max temp) and 8:59 (probe 2, 176c max temp).Probe 2 issued a reflected power error.Both probes then ablated for 1:10 at 95w (115c max temp for probe 2 and 140c max temp for probe 3).This marked the end of the case.The probe (b)(6) (14 uses, 9:02) was returned with a broken tip (not included), and the brass cap/antenna was still intact.The cannula was also bent at the handle.No further information was available so the root cause of the damage is unknown.Lot ml20035107 was reviewed (in process sn (b)(6)).Manufacture date: 4/17/20 expiration date: 12/1/23 probe sn 5 had a flex failure.There were no other problems seen during the manufacturing and testing of this lot.

• Brand Name: NEUWAVE PR 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: orla o'mahony ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 13953348
• Report Number: 3008769756-2022-00013
• Device Sequence Number: 11957641
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: 00853719006395
• 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
• Report Date (Section B): 03/30/2022

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: PR15
• Device Catalogue Number: PR15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/22/2022
• 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