MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-25 for NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE 0700001000 manufactured by Stryker Instruments-kalamazoo.
[5573433]
It was reported that the device was tagged for repair at the user facility, the tag stated that there were exposed copper wires. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[5891277]
It was reported that the device was tagged for repair at the user facility, the tag stated that there were exposed copper wires. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[13075140]
Evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
[13452386]
The field service technician was able to confirm the reported event. The root cause was determined to be due the power cord plug exposed wires. Based on the risk documentation, the insulation can break down due to being exposed to rough surfaces, sharp edges or corners. The technician replaced the power cord and the rover functioned as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-01115 |
| MDR Report Key | 4633513 |
| Report Source | 06 |
| Date Received | 2015-03-25 |
| Date of Report | 2015-03-02 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-04-13 |
| Device Manufacturer Date | 2006-08-02 |
| Date Added to Maude | 2015-03-25 |
| 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 | 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 | 2015-03-25 |
| Catalog Number | 0700001000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-03-25 |