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

Model Number	PR20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/17/2022.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.
Event or Problem Description
It was reported that during a liver ablation while applying constant pressure against the rib the probe broke and fragmented 3-4 cm distal to the green hub.The fragment was retrieved and the case rescheduled for another day.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/16/2022.No call home data could be found in the given date range for this hospital.No device will be returned to neuwave for further investigation.The complaint description stated that the cause of the broken probe was due to the physician's use of force against the patient's ribs while inserting.The broken probe cannot be verified since it was not returned, and no images were received.No lot information was provided therefore no lot history review could be performed.

• Brand Name: NEUWAVE PR PROBE 20CM 17GA
• 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: orla o'mahony ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 14432274
• Report Number: 3008769756-2022-00026
• Device Sequence Number: 6551953
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 00853719006418
• Combination Product (Y/N): N
• 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): 05/17/2022

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: PR20
• Device Catalogue Number: PR20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown