MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-31 for LIGHT GUIDE CABLE WA03210A * manufactured by Olympus.
[1841379]
During the endoscopic vein harvest, the light cord attached to the camera and vasoview broke. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1996562 |
| MDR Report Key | 1996562 |
| Date Received | 2011-01-31 |
| Date of Report | 2011-01-26 |
| Date of Event | 2010-11-16 |
| Report Date | 2011-01-26 |
| Date Reported to FDA | 2011-01-31 |
| Date Added to Maude | 2011-02-18 |
| 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 | 0 |
| 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 | LIGHT GUIDE CABLE |
| Generic Name | LIGHT CORD |
| Product Code | EWY |
| Date Received | 2011-01-31 |
| Model Number | WA03210A |
| Catalog Number | * |
| Lot Number | N/A |
| ID Number | * |
| Device Age | 9 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | 3500 COOPERATE BLVD CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-31 |