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

Model Number	PR20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.
Event or Problem Description
It was reported that during an unknown procedure that the distal end of the probe tip broke.Another like device was used to complete the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/19/2021.H6: component code: cannula (g04019).Investigation summary.Call home was reviewed for system nm15nea00319 on 4/21/2021.A pr20, nm20ncc15700, was connected to channel 3 and tested.A reflected power error was issued.The probe was retested and then disconnected.A new probe was connected and used for the remainder of the case without issue.Probe nm20ncc15700 (0 uses) was investigated at neuwave.The probe returned with the cannula separated from the probe head.The cannula itself had multiple bends with damage as well (please see images for damage).The root cause of the damage is unknown.Analysis does not reveal the root cause of the reported failure.No further investigation will be conducted on this complaint.Lot ml20095610 was reviewed (in process sn (b)(6)).Manufacture date: 10/12/20.Expiration date: 5/31/24.There were no problems seen during the manufacturing and testing of this lot.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/13/2023.Investigation summary: call home revealed a reflected power error.The probe was retested and then disconnected.A new probe was connected and used for the remainder of the case without issue.The probe was returned with the cannula disconnected from the probe head, as well as multiple bends and damage.The root cause is unknown.Lot ml20095610 was reviewed (in process sn (b)(6)).Manufacture date: 10/12/20.Expiration date: 5/31/24.There were no problems seen during the manufacturing and testing of this lot.

• 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 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: kara ditty-bovard ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 11867216
• Report Number: 3008769756-2021-00018
• Device Sequence Number: 1100310
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 853719006418
• 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,Followup
• Report Date (Section B): 04/22/2021

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 Expiration Date: 05/31/2024
• Device Model Number: PR20
• Device Catalogue Number: PR20
• Device Lot Number: ML20095610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 03/28/2023
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/19/2021; 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown