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

Model Number	PR20
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure that the pr20 broke three quarters of the way down.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.Batch #: ml20095611.Additional information was requested and the following was obtained: the cannula nor the tip of the probe broke off.The probe did not break off inside the patient.The procedure aborted and did not get rescheduled.The patient did not suffer any consequences.Probes are both being sent out soon.Investigation summary: call home was reviewed for system (b)(4).A pr20xt, (b)(4), was connected to channel 3, tested, and put into tissu-loc.There was a probe temperature error on probe 3.The probe was retested and put into tissu-loc, then issued another such error.The probe was retested again then set to ablate for 10:00, 65w.The ablation completed without error.One and a half minutes later, the probe issued a high number of probe temperature measurement errors.A new probe, (b)(4), was connected to channel 2 and tested.There was a probe temperature measurement error one second into the test.Another such error occurred 5 seconds after the test fail.Both probes were disconnected and this marked the end of the case.Probe (b)(4) (0 uses) was investigated at neuwave.The cannula was broken off at the 16cm mark from the tip.There was also heat shrink and thermocouple damage from the 3-8cm mark from the tip (see additional images).The root cause of the damage is unknown since no additional information was available.Analysis does not reveal the root cause of the reported failure.No further investigation will be conducted on this complaint.Complaint information will be included in complaint trending that is reviewed by the applicable pqss drb on a regular basis to determine if further action is necessary.Lot ml20095611 was reviewed (in process sn (b)(4)).Manufacture date: 10/8/2020.Expiration date: 5/31/2024.There were no problems seen during the manufacturing and testing of this lot.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: NEUWAVE PR PROBE 20CM 17GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• MDR Report Key: 12720371
• Report Number: 3008769756-2021-00093
• Device Sequence Number: 3984316
• 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
• Report Date (Section B): 10/29/2021

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: 10/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1