MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE SR PROBE 25CM 13GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	NWSR25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information was requested, and the following was obtained: what were the indications for surgery? patient has colorectal cancer with mets to the liver; came in for liver resection/ablation of liver tumors.Did the procedure start laparoscopic and need to be converted to open to find broken pieces? no, broken pieces were found prior to the surgeon deciding to go open.Was the covert to open planned or caused by difficulties experienced with device or other contributing factors? surgery was converted to open due to difficulty of the robot (davinci) arms being in the way of placing neuwave probe are any photos available? yes.How many probes were being used? one probe was being used.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 liver ablation.Resection the probe broke off inside the patient.The probe and all of the pieces were located and removed from the patient.The procedure was converted to open and was completed with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/18/2021.Investigation summary: the attached photos were reviewed.They displayed a probe with a broken tip (tip included in another photo).Call home was reviewed for system nm14nea00267 on (b)(6) 2021.A sn (b)(6), nm20nda04724, was connected to channel 3 and tested.A reflected power error was seen.The probe was tested twice more and then disconnected.A new probe was used for the remainder of the case.Probe nm20nda04724 (0 uses) was investigated at neuwave.The probe had a broken tip (see images).The root cause of the damage is unknown.Analysis does not reveal the root cause of the reported failure.Lot ml20045151 was reviewed (in process sn (b)(6)).Manufacture date: 5/12/21.Expiration date: 1/1/24.

• Brand Name: NEUWAVE SR PROBE 25CM 13GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 11825485
• Report Number: 3008769756-2021-00013
• Device Sequence Number: 11051228
• Product Code: NEY
• UDI-Device Identifier: 00853719006432
• UDI-Public: 00853719006432
• 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): 04/15/2021

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: NWSR25
• Device Catalogue Number: NWSR25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/18/2021
• Patient Sequence Number: 1