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

Catalog Number	APTUBE1
Medical Device Problem Codes	Defective Component (2292); Out-Of-Box Failure (2311); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was no visible damage to the returned device.Conclusions: evaluation of the returned device confirmed that the red cap could not be unscrewed with reasonable force.The root cause of this complaint could not be determined.These devices are 100% visually inspected during inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a microneurosurgery procedure, the hospital staff noticed that the red cap of the apollo irrigation tubing (tubing) would not twist off and therefore, the male end could not be used.The defective tubing was found prior to use and was not used for the procedure.The procedure was completed using a new tubing.

• Brand Name: APOLLO IRRIGATION TUBING
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5485931
• Report Number: 3005168196-2016-00290
• Device Sequence Number: 16218539
• Product Code: GWG
• UDI-Device Identifier: 00814548013602
• UDI-Public: 00814548013602
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2016

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: Health Professional
• Device Expiration Date: 02/03/2018
• Device Catalogue Number: APTUBE1
• Device Lot Number: A62517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2016
• Initial Report FDA Received Date: 03/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1