MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-24 for VITAL VUE * 8886828006 manufactured by Covidien United States Surgical Corp.
[3109688]
During setup, fluid would not flow through vital vue tip while suction part of equipment was on. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2888342 |
| MDR Report Key | 2888342 |
| Date Received | 2012-12-24 |
| Date of Report | 2012-12-24 |
| Report Date | 2012-12-24 |
| Date Reported to FDA | 2012-12-24 |
| Date Added to Maude | 2012-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE |
| Generic Name | ILLUMINATOR, FIBEROPTIC, SURGICAL |
| Product Code | HBI |
| Date Received | 2012-12-24 |
| Model Number | * |
| Catalog Number | 8886828006 |
| Lot Number | 1343165 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN UNITED STATES SURGICAL CORP |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-24 |