MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for ARTEMIS EYE APY28 manufactured by Penumbra, Inc..
[187955647]
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. 3005168196-2020-00454.
Patient Sequence No: 1, Text Type: N, H10
[187955648]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2020-00453 |
| MDR Report Key | 9889877 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VERONICA FARRIS |
| Manufacturer Street | ONE PENUMBRA PLACE |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal | 94502 |
| Manufacturer Phone | 5107483200 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEMIS EYE |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | APY28 |
| Lot Number | F94108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENUMBRA, INC. |
| Manufacturer Address | ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502 |
| Product Code | --- |
| Date Received | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |