MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-14 for NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE 0700001000 manufactured by Stryker Instruments-kalamazoo.
[5675176]
It was reported that during docking at the user facility the unit was not able to dock, which caused a surgical delay of 30 minutes. No medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[6032167]
It was reported that during docking at the user facility, the unit was not able to dock, which caused a surgical delay of 30 minutes. No medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[13145099]
Evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
[14034647]
The device was repaired by a field service technician at the user facility and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-01366 |
| MDR Report Key | 4690633 |
| Report Source | 06 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-03-18 |
| Date of Event | 2015-03-11 |
| Date Mfgr Received | 2015-05-27 |
| Device Manufacturer Date | 2006-03-28 |
| Date Added to Maude | 2015-04-14 |
| 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 | 2015-04-14 |
| Catalog Number | 0700001000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-04-14 |