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

Model Number	NWSR25
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/13/2017.Batch # unk.The report is being sent by request from fda stating that initial report has not been received for 3008769756-2017-00015.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 resection procedure, the sr25 probe was placed in to small of an ultrasound probe guidance tool and broke the tip off probe.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient.

• 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
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: kara ditty-bovard ; 3529 anderson st; madison 53704 ; 6107428552
• MDR Report Key: 6996536
• Report Number: 3008769756-2017-00015
• Device Sequence Number: 2857373
• Product Code: NEY
• UDI-Device Identifier: 00853719006432
• UDI-Public: 00853719006432
• Combination Product (Y/N): N
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/02/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown