MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-24 for CONSTELLATION VISION SYSTEM * manufactured by Alcon Research, Ltd.
[15510018]
Using constellation vitrectomy machine. The infusion tubing stopped working, we couldn't turn it on and off even after turning machine on or off. We got several system advisory codes and they were 3464, 2252, 6204. We ended up switching out and using a back up machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2770298 |
| MDR Report Key | 2770298 |
| Date Received | 2012-08-24 |
| Date of Report | 2011-07-18 |
| Date of Event | 2011-07-13 |
| Report Date | 2011-07-18 |
| Date Reported to FDA | 2012-08-24 |
| Date Added to Maude | 2012-10-03 |
| 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 | CONSTELLATION VISION SYSTEM |
| Generic Name | VITRECTOMY, INSTRUMENT, CUTTER, SYSTEM |
| Product Code | MLZ |
| Date Received | 2012-08-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD |
| Manufacturer Address | 714 COLUMBIA AVE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-24 |