MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE; NRY

Model Number	PMXENGN-A
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned engine confirmed a malfunction with the indicator lights.During functional testing, the engine was powered on and achieved vacuum pressure within specification, but no vacuum indicator light illuminated.The engine housing was opened, and no damage was observed.The engine was tested with a demonstration power button, but the same issue occurred.This indicates that an error within the main pcb may be contributing to the indicator lights malfunction.Penumbra engines are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra engine (engine), a penumbra engine canister (canister), and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, after the tubing was removed from the patient, the engine was on the back table and it was reported that none of the indicator lights illuminated when the engine was generating aspiration.Therefore, the engine was no longer used.On (b)(6) 2021, the second check was performed and the issue resolved.It was unknown whether the same canister was in use at this time.The procedure was completed using a stent retriever.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11417416
• Report Number: 3005168196-2021-00406
• Device Sequence Number: 11866358
• Product Code: NRY
• UDI-Device Identifier: 00815948020023
• UDI-Public: 00815948020023
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2021
• Report Date (Section F): 01/01/2005

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: PMXENGN-A
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10150-41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005