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	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ptc liver procedure that the two probes were tested and passed.The probes were inserted into the patient.The probe in channel two would not start and kept shutting off.When the probe was removed it was found that the tip had broken off.The tip was found and recovered from the liver.Another like device was used to continue with the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/12/2024.D4 batch #: unknown.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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 is pending for the finished device lot number.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: 9/9/2024 corrected data: d4 udi # the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was obtained: an internal rapid response call was held on 9/5/2024 to discuss the broken probe tip event and results.The rep that was in the case gave the team a summary of the event.The doctor used 2 probes with a probe clip and started doing ptc.The probes were working fine until suddenly 1 of the probes kept shutting off.After asking the surgeon a few questions, the rep recommended pulling the probes out.The doctor pulled out the probes with the clip still attached and the doctor and rep were able to confirm the probe tip was broken on the device that kept shutting off.While the rep went to go get another probe, the surgeon retrieved the broken piece of the probe.The surgeon handed the piece to the scrub tech who then placed it on the back table.Then the scrub tech put the piece inside of the sterile cup.The cup was then handed to the rep, who proceeded to take a photo of the piece inside the cup.The rep left the piece in the sterile cup when she sent the broken probe and retrieved piece back for analysis.It was confirmed that the 2 probes were 1.5cm apart ¿ held by the probe clip and both probes were activated at the same time.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/16/2024.Additional information was obtained: dr.Informed me that the tip was in the part of the liver they had removed and found it after the case.He has done a scan and there is nothing in the patient at this point.Investigation summary: call home revealed reflected power errors.The returned probe's tip was broken off and not included.There was evidence of thermal damage.The antenna and brass cap were disconnected but included.The potential cause of the damage is unknown due to the amount of damage seen, as well as the tip not returning.A search of nonconformities (ncs) was performed for lot ml23108618.There were no observed nonconformities for this lot.Manufacture date: 10/1/2023.Expiration date: 6/30/2027.

• 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 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 19959824
• Report Number: 3008769756-2024-00017
• Device Sequence Number: 17926385
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: (01)00853719006395(17)270630(10)ML23108618
• 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): 08/12/2024

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: ML23108618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 09/10/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown