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 2017-07-06 for APOLLO WAND AP9 manufactured by Penumbra, Inc..
[79262560]
The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10
[79262561]
During preparation for a micro neurosurgery, the hospital staff noticed that the apollo wand (wand) was not working properly upon attaching it to the apollo generator and testing the apollo system. It was reported that the wire within the wand was not activated when depressing the apollo generator foot pedal (foot pedal) on the apollo system. Therefore, the physician opened a new wand, tested it and used it to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2017-01097 |
| MDR Report Key | 6691748 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-06 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2017-07-06 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APOLLO WAND |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2017-07-06 |
| Returned To Mfg | 2017-06-14 |
| Catalog Number | AP9 |
| Lot Number | F73737 |
| ID Number | NI |
| Device Expiration Date | 2018-01-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENUMBRA, INC. |
| Manufacturer Address | ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-06 |