MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. PR20XT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR20XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ablation but tip broke off in patient.No patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/13/2023.B3: event year only reported: 2023.D4 batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what the broken probe tip removed from the patient? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/5/2023.Additional information was requested and the following was obtained: was the broken probe tip removed from the patient? the physician's post case asked if it was mri safe so i assume it was not removed.What is the location and size of the tumor being treated? liver, size unknown.What was the probe insertion approach? unsure if open or lap.Was there any resistance during probe insertion? unknown.Were any lateral forces applied during probe insertion? unknown.Are there any intentions/plans of retrieving the broken piece from the patient? i don't believe so as accounted wanted to confirm if mri safe.What is the patient's current status? case was completed.Call home revealed multiple reflected power errors.No device will be returned to neuwave since it was discarded.The potential cause is unknown.A search of nonconformities (ncs) was performed for lot ml22077920.There were no observed nonconformities for this lot.Manufacture date: 7/1/2022.Expiration date: 3/31/2026.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/11/2023.The photo was reviewed.This displays a probe with a broken probe tip.No serial number was included.

• Brand Name: PR20XT
• 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: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 17738935
• Report Number: 3008769756-2023-00032
• Device Sequence Number: 5472644
• 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,Followup
• Report Date (Section B): 09/13/2023

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: PR20XT
• Device Lot Number: ML22077920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 10/10/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/05/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown