MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	PR20XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? if yes, please specify and inform what was done to help the patient.No, the instrument was unpacked and immediately replaced.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown ablation there was a broken needle.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/14/2022.Investigation summary; since this occurred in switzerland, there is no call home available.Probe nm21nhc45921 (0 uses) was investigated at neuwave.The returned probe's lemo nut was disconnected and missing.This causes an incomplete connection with the pdm, therefore the probe is unable to register with the system.It may look as if no probe is connected.Manufacturing also investigated the issue and concluded this probe was built by an employee that is no longer with neuwave.The probe did not have enough adhesive holding the lemo nut in place.A re-training was completed in manufacturing to go over this issue.Lot ml21086828 was reviewed (in process sn (b)(6)).Manufacture date: 9/13/21.Expiration date: 4/30/25.The cannula for probe sn (b)(6) failed the continuity test.This cannula was replaced.No further problems were seen during the manufacturing and testing of this lot.

• Brand Name: NEUWAVE PR XT PROBE 20CM 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: 14621229
• Report Number: 3008769756-2022-00029
• Device Sequence Number: 5367462
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 00853719006425
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: PR20XT
• Device Catalogue Number: PR20XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/14/2022
• 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