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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the facility was pulling devices for an ablation case it was noticed that the product box was for pr20xt but the product inside was pr15xt and the label on the box says pr15xt.There were no consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Investigation summary: the probe was returned, where is was confirmed that the barcode, tyvek, and probe inside were all for pr15xt, and the square label on the boxes were for pr20xts.There is no lot information available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2023.A search of nonconformities (ncs) was performed for lot ml22027437.One nc was created from this complaint: (b)(4).

• 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 WI 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: orla o'mahony ; 3529 anderson st; madison, WI 53704 ; 329348013
• MDR Report Key: 15462636
• Report Number: 3008769756-2022-00050
• Device Sequence Number: 6873885
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 853719006425
• 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): 09/21/2022

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
• Device Lot Number: ML22027437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown