MAUDE Adverse Event Report: PENUMBRA, INC. ARTEMIS EYE TABLET; GWG

Catalog Number APYTAB

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2020-00453.

Event Description

The patient was undergoing an endoscopic intracerebral hematoma (ich) evacuation using an artemis eye, artemis eye tablet, energy platform, and bipolar cautery device.During the procedure, the physician used a bipolar cautery on an active bleeder through the working channel of an artemis eye.The energy platform was set to 35w.While delivering energy to the vessel with the bipolar cautery device, a ¿camera connection error¿ message was displayed on the screen of the artemis eye tablet, and the camera view on the artemis eye tablet went black.It was reported that this issue occurred at least three times, and the camera would work once the power was stopped.Subsequently, the physician decided not to use the artemis eye and artemis eye tablet for the remainder of the procedure.The procedure was completed with open surgery to control the patient bleeding.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section has been corrected: 1.Section b.Box 5.Describe event or problem although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to a serious injury or death.Therefore, this is not considered a reportable event.This report is associated with mfr report number: 1.3005168196-2020-00453.

Event Description

The patient was undergoing an endoscopic intracerebral hematoma (ich) evacuation using an artemis eye device, energy platform, and bipolar electrocautery device.During the procedure, when the bipolar electrocautery device was activated, the artemis eye tablet live video display temporarily went black.After deactivation of the bipolar electrocautery device, the artemis eye tablet displayed live video from the artemis eye as intended.There was no adverse effect to the patient associated with this incident.The physician decided to convert to open surgery to treat the bleeding and the case was ended.This decision was unrelated to the artemis eye device.

• Brand Name: ARTEMIS EYE TABLET
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9889873
• MDR Text Key: 187956464
• Report Number: 3005168196-2020-00454
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): Y
• PMA/PMN Number: K171332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: APYTAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR