MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC CERTUS 140 2.45 GHZ ABLATION SYSTEM; MICROWAVE ABLATION SYSTEM AND ACCESSORIES

Model Number	CERTUS PR PROBE
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The probe was not returned to neuwave for evaluation.A review of the device lot history records indicated the probe met all specifications and passed all manufacturing tests.System logs were reviewed and indicate the reported temperature errors.No additional investigation is planned unless the probe is returned to neuwave.
Event or Problem Description
The physician was using a 20cm pr probe to perform an ablation.During the case, the physician indicated that several temperature errors occurred on the probe.The probe was retested and passed the tests.After the completion of the procedure, a burn was noticed on the patient's skin.No information was provided regarding the size, degree or required treatment of the skin burn.

• Brand Name: CERTUS 140 2.45 GHZ ABLATION SYSTEM
• Common Device Name: MICROWAVE ABLATION SYSTEM AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC; 3529 anderson street; madison WI 53704
• MDR Report Key: 6664709
• Report Number: 3008769756-2017-00012
• Device Sequence Number: 1882048
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 00853719006418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

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: Physician
• Device Expiration Date: 05/01/2019
• Device Model Number: CERTUS PR PROBE
• Device Catalogue Number: PR20
• Device Lot Number: ML17022619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR