MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE LK PROBE 20CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	LK20
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	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.
Event or Problem Description
It was reported that during a liver ablation the probe broke while in the patients liver.There were no patient consequences and there is no additional information.
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2021.H1: mdr decision: not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Based on the condition of the returned device, it was discovered that the probe tip was intact but the cannula was broken.No pieces of device was missing and there was nothing left in patient.No patient consequence reported.

• Brand Name: NEUWAVE LK PROBE 20CM 17GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 10931434
• Report Number: 3008769756-2020-00031
• Device Sequence Number: 2469916
• Product Code: NEY
• UDI-Device Identifier: 00853719006371
• UDI-Public: 00853719006371
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: LK20
• Device Catalogue Number: LK20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention