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

Catalog Number	APG1
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cord to the foot pedal of the apollo generator (generator) was cut in half.Conclusions: evaluation of the returned device revealed that the pump was functional.The returned pump was connected to the returned generator.Then a demonstration wand and demonstration foot pedal were connected to the generator.The pump and generator were powered on and no leaks were observed.Therefore, the pump was functional.Due to the generators foot pedal cord being damaged, the generator was deemed nonfunctional.The root cause of the leak reported in the complaint could not be determined.The wands that were mentioned in the complaint were not returned for evaluation.All penumbra apollo pumps and generators are visually inspected during incoming quality inspection.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 numbers: 3005168196-2016-01595; 3005168196-2016-01596.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a microneurosurgery procedure using an apollo generator (generator) and apollo wands (wand).During the procedure, while using the wand the physician noticed there was a leak at the hub of the wand and, therefore, switched to a new wand.However, the physician noticed that the hub of the new wand was leaking as well.The physician completed the procedure using this wand despite the leak.The physician also noticed the cord of the apollo generator foot pedal was severed in half, and completed the procedure by taping the cord back together.There was no report of an adverse effect to the patient.

• Brand Name: APOLLO GENERATOR
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6094727
• Report Number: 3005168196-2016-01594
• Device Sequence Number: 16544775
• Product Code: GWG
• UDI-Device Identifier: 00814548012704
• UDI-Public: 00814548012704
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152699
• 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): 10/13/2016

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 Catalogue Number: APG1
• Device Lot Number: F60068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2016
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR