MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-06 for NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE 0700001000 manufactured by Stryker Instruments-kalamazoo.
[5790538]
It was reported that during a surgical procedure at the user facility the device wouldn't charge which caused a 30 minute delay to the procedure. Back-up equipment was used to successfully complete the procedure. No medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[13383656]
Failure analysis is in progress.
Patient Sequence No: 1, Text Type: N, H10
[20038051]
It was reported that during a surgical procedure at the user facility, the device wouldn't charge which caused a 30 minute delay to the procedure. Back-up equipment was used to successfully complete the procedure. No medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[20284817]
The reported event was confirmed. The device was repaired on site and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-01643 |
| MDR Report Key | 4753849 |
| Report Source | 06 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-04-22 |
| Date of Event | 2015-04-22 |
| Date Mfgr Received | 2015-06-17 |
| Date Added to Maude | 2015-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2015-05-06 |
| Catalog Number | 0700001000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-06 |