MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-04-20 for NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE 0700001000 manufactured by Stryker Instruments-kalamazoo.
[5724194]
It was reported that during equipment testing conducted by a field service technician at the user facility the power cord of the device was broken, exposing 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
[13239425]
Failure analysis is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[19607466]
It was reported that during equipment testing conducted by a field service technician at the user facility the power cord of the device was broken, exposing 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
[20135317]
The first date the service technician became aware of the power cord issue was (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
[26268772]
Device was repaired in the field by a field service technician and returned to service.
Patient Sequence No: 1, Text Type: N, H10
[26268773]
It was reported that during equipment testing conducted by a field service technician at the user facility the power cord of the device was broken, exposing 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
| Report Number | 0001811755-2015-01451 |
| MDR Report Key | 4707227 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-04-20 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-03-09 |
| Date Mfgr Received | 2015-06-29 |
| Device Manufacturer Date | 2007-05-22 |
| Date Added to Maude | 2015-04-20 |
| 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 | 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 | 2015-04-20 |
| 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 | 2015-04-20 |