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	04/15/2021
Type of Reportable Event	Malfunction
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.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 an unknown procedure while cleaning charred tissue from the probe the tip broke off.The case was completed with a single probe and no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/15/2021.Investigation summary: the probe returned with a broken probe tip.The root cause of the broken probe tip was due to the user cleaning off the char and accidentally pulling off the tip, as explained by the complaint text.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Lot ml20085499 was reviewed (in process sn (b)(6)).Manufacture date: 9/10/20.Expiration date: 4/30/24.

• 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
• MDR Report Key: 11826806
• Report Number: 3008769756-2021-00015
• Device Sequence Number: 1153706
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 00853719006418
• 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): 04/16/2021

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: PR20
• Device Catalogue Number: PR20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/15/2021
• Patient Sequence Number: 1