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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; NRY
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PENUMBRA, INC. PENUMBRA ENGINE CANISTER; NRY Back to Search Results
Device Problem Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2019
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
 
Event Description
During preparation for a thrombectomy procedure, the hospital staff found that a penumbra engine (engine) was losing suction while in use with a penumbra engine canister (canister).The malfunction was found prior to use and, therefore, the procedure was completed using a new canister and the same engine.
 
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Brand Name
PENUMBRA ENGINE CANISTER
Type of Device
NRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key8745800
MDR Text Key149664633
Report Number3005168196-2019-01277
Device Sequence Number1
Product Code NRY
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,05/30/2019
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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