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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. APOLLO WAND; GWG
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PENUMBRA, INC. APOLLO WAND; GWG Back to Search Results
Catalog Number AP9
Medical Device Problem Codes Mechanical Problem (1384); Out-Of-Box Failure (2311); Defective Device (2588)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/20/2017
Type of Reportable Event Malfunction
Additional 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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-01392.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a microneurosurgery procedure, the physician noticed that two apollo wands (wand) were not vibrating.The defective wands were found prior to use and therefore, were not used in the procedure.The procedure was completed using a new wand.
 
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Brand Name
APOLLO WAND
Common Device Name
GWG
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key6790635
Report Number3005168196-2017-01391
Device Sequence Number19272504
Product Code GWG
UDI-Device Identifier00814548016344
UDI-Public00814548016344
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K152699
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/21/2017
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 Physician
Device Expiration Date12/19/2017
Device Catalogue NumberAP9
Device Lot NumberF73213
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2017
Initial Report FDA Received Date08/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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