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

Catalog Number	PR15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/7/2024.B3: event year only reported: 2024 d4 batch #: unknown.Additional information was requested and the following was obtained: the provider made his initial incision and when trying to place the probe the tip broke off.It was not dropped or anything done to it other than the normal/routine check with the machine that the probe is functioning.Was the blade that broke off removed from the patient? yes.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 an ablation the probe tip broke off when they removed it from the box upon usage.No patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/9/2024.Investigation summary: there is no call home data available since this system has not called home since 11/21/2021.The probe also was not connected during the case, so it would not have registered in call home.The returned probe's cannula was bent at the 4cm mark from the tip.The potential cause of the bend is unknown.No tip break was seen with the returned probe as described in the complaint description.A search of nonconformities (ncs) was performed for lot ml24059243.There were no observed nonconformities for 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 WI 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison WI 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 20630511
• Report Number: 3008769756-2024-00026
• Device Sequence Number: 7392973
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: (01)00853719006395(17)280131(10)ML24059243
• 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): 11/07/2024

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 Catalogue Number: PR15
• Device Lot Number: ML24059243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown