MAUDE Adverse Event Report: PENUMBRA, INC. APOLLO WAND; GWG

Catalog Number	AP9
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was no visible damage to the apollo wand (wand).Conclusions: evaluation of the returned device could not confirm the complaint.The wand was coupled to a demonstration apollo unit and functioned as intended.If the wand is not properly coupled to the apollo unit, the knob may not seat properly with the transducer, and lack of vibration may be experienced.Apollo wands are 100% visually evaluated during in-process inspection.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 microneurosurgery procedure using an apollo wand (wand).During the procedure, the wand stopped vibrating.The procedure was completed using a new wand.There was no report of an adverse effect to the patient.

• Brand Name: APOLLO WAND
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5442915
• Report Number: 3005168196-2016-00181
• Device Sequence Number: 273586
• Product Code: GWG
• UDI-Device Identifier: 00814548013589
• UDI-Public: 00814548013589
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2016

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 Date: 02/06/2016
• Device Catalogue Number: AP9
• Device Lot Number: F62558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2016
• Initial Report FDA Received Date: 02/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1