MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; QEW

Catalog Number	IAPS3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the canister lid was returned unscrewed from the base and sitting loosely on top.None of the retained clips were fastened, as if the canister lid was removed.No damages or abnormalities were observed with the canister.During functional testing, the canister lid was screwed on properly and tested with an engine pump.The canister functioned as expected and held pressure within specification.Conclusions: evaluation of the returned canister revealed the lid was unscrewed from the canister body.None of the clips were attached which indicates that the lid was removed at some point, likely during trouble shooting.The canister lid was re-attached and was tested with a demonstration engine pump.The canister functioned as expected and held pressure within specification.The root cause of this issue could not be determined.Penumbra devices are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a medical procedure using a penumbra engine canister (canister) and penumbra engine (engine).During the procedure, the hospital staff seated the canister on the engine.While the engine was powered on, not all four of the indicator lights were illuminated; therefore, the canister was removed.The procedure was completed using another canister and the same engine.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9507230
• Report Number: 3005168196-2019-02378
• Device Sequence Number: 13838408
• Product Code: QEW
• UDI-Device Identifier: 00814548019703
• UDI-Public: 00814548019703
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2019
• 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 Catalogue Number: IAPS3
• Device Lot Number: S10296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• 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: 11/26/2019
• Initial Report FDA Received Date: 12/20/2019
• 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