MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-11 for APOLLO WAND AP9 manufactured by Penumbra, Inc..
[82808160]
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. 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 number: 3005168196-2017-01392. The hospital disposed of the device.
Patient Sequence No: 1, Text Type: N, H10
[82808161]
During preparation for a microneurosurgery procedure, the physician noticed that two apollo wands (wand) were not vibrating. The defective wands were found prior to use and therefore, were not used in the procedure. The procedure was completed using a new wand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2017-01391 |
| MDR Report Key | 6790635 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-11 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-20 |
| Date Mfgr Received | 2017-07-21 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2017-08-11 |
| 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 | 2017-08-11 |
| Catalog Number | AP9 |
| Lot Number | F73213 |
| ID Number | NI |
| Device Expiration Date | 2017-12-19 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-11 |