MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-16 for NEPTUNE 2 ROVER ULTRA (120V) 0702001000 manufactured by Stryker Instruments-kalamazoo.
[82988294]
It was reported that blood was sucked into the smoke filter and was leaking by the smoke filter's port. There was no patent involvement or procedural delays associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-01754 |
| MDR Report Key | 6797816 |
| Date Received | 2017-08-16 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2014-05-28 |
| Date Added to Maude | 2017-08-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | NEPTUNE 2 ROVER ULTRA (120V) |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2017-08-16 |
| Catalog Number | 0702001000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-16 |