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 2017-10-25 for APOLLO WAND AP9 manufactured by Penumbra, Inc..
[90904823]
Results: the apollo wand (wand) leaked at the connection between the apollo generator (generator) and the acrylonitrile butadiene styrene (abs) knob. Conclusions: evaluation of the returned device confirmed that the wand leaked. The wand was connected to an apollo system and was able to aspirate, irrigate, and vibrate; however, the wand leaked where the abs knob connects to the generator. The root cause of the leak could not be determined. Penumbra wands are visually inspected during in-process inspection and during quality inspection after manufacturing the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Patient Sequence No: 1, Text Type: N, H10
[90904824]
During preparation for a microneurosurgery procedure, the physician noticed the apollo wand (wand) was leaking from the connection to the apollo generator. The damaged wand was noticed prior to use in the patient and therefore, was not used in the procedure. The procedure was completed using a new wand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2017-01859 |
| MDR Report Key | 6976979 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-25 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2017-04-20 |
| Date Added to Maude | 2017-10-25 |
| 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 | MISS 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 | 2017-10-25 |
| Returned To Mfg | 2017-10-05 |
| Catalog Number | AP9 |
| Lot Number | C02159 |
| ID Number | NI |
| Device Expiration Date | 2018-04-20 |
| Operator | PHYSICIAN |
| 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 | 2017-10-25 |