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	Foreign Body In Patient (2687)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: was the portion of the probe completely removed from the patient without additional intervention? the probe tip was left in the patient and visualized in post procedure ct.A trocar was used to introduce the probe.Was not observed that the physician encountered resistance when placing the probe lateral force was not observed when introducing the probe.The physician did not experience any abnormal situations when placing the probe.No error message occurred during the ablation.The procedure was completed with the probe.The broken tip was observed after the probe was removed from the patient.No plans to remove the probe tip.Patient's current status is not known.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a bone ablation case a small portion of the pr20 ablation probe appeared to break off into the patient¿s bone which was visualized through ct.The procedure was completed using the probe previously mentioned.
Additional Manufacturer Narrative
(b)(4).Investigation summary: call home revealed no errors or issues.Temperatures were normal for the time and power used.The probe in question was returned to neuwave.The probe cannula was bent, and the tip was broken.There was also damage to the heat shrink and thermocouples.According to the additional information, a trocar was used to introduce the probe.The physician stated there was no lateral force used to position the probe.The root cause of the damage is unknown.Device history lot: lot ml19014071 was investigated (in process sn 3).Manufacture date: 3/7/19.Expiration date: 10/1/22.Probe sn 25's inner conductor was out of spec.Probe sn 5 had fep cover layer damaged.Rework was performed to resolve the issue.

• 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: 13654490
• Report Number: 3008769756-2022-00009
• Device Sequence Number: 5749709
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 00853719006418
• 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): 03/02/2022

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: PR20
• Device Catalogue Number: PR20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/30/2022
• 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