MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR20XT
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), date sent: 5/24/2024.B3: event year only reported: 2024.D4 batch #: unknown.Additional information was requested and the following was obtained: what was the indication for the ablation? microwave-assisted pre-transection coagulation for resection of liver tumor.Please describe the insertion approach: trans cutaneous laparoscopic.Was any resistance encountered during probe insertion? normal resistance common in cirrhotic liver.Were any lateral forces applied during probe insertion? normal force common for this procedure.Was the probe able to ablate the tumor prior to issue occurring? yes.Did the probe work for a while and then stop? yes.How much of the probe was broken off (length of the piece) in the patient? approximately 1 cm.What is the patient's current status? piece was retrieved.Additional 2 hours of surgery time.Patient was discharged.Is the probe available for engineering review? probe was sequestered.May be available.Will try and obtain it.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 the ablation the probe broke in the patient and had to be surgically removed.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/28/2024.Additional information was received: the surgeon was ablating in the or and they went to pull the probe out of the patient but it was stuck in the patient's liver.It took them almost 2 hours to get it out of the patient.Laparoscopic ptc procedure was done at 95 watts within 1 minute cycle time.Surgeon used 2 probes with the spacing being 1.5 cm.They got a reflective power error on one probe.They kept trying to restart it but same error persisted.When retrieved surgeon noticed 1 cm of distal tip was missing from the probe and realized in the liver.Surgeon was using a laparoscopic approach.Was the probe able to ablate the tumor prior to issue occurring? not an ablation.Using mw for ptc what led then user to pull the probe out? repeated reflected power error (see call home).
Additional Manufacturer Narrative
(b)(4).Date sent: 6/19/2024 call home revealed reflected power errors.No device will be returned to neuwave for further investigation.Potential cause unknown.A search of nonconformities (ncs) was performed for lot ml23078382.There were no observed nonconformities for this lot.Manufacture date: 7/1/2023.Expiration date: 3/31/2027.

• Brand Name: NEUWAVE PR XT PROBE 20CM 15GA
• 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: 19390742
• Report Number: 3008769756-2024-00009
• Device Sequence Number: 17881446
• 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): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PR20XT
• Device Lot Number: ML23078382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 05/30/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/28/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown