MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-01 for CUSA * manufactured by Valleylab.
[421705]
A cusa machine was set up for a craniotomy pre-operatively. When using cusa intra-operatively, a leak was noticed in the tubing. Contamination of the instruments in the sterile field was suspected; surgeon was notified; equipment was removed and replaced with new tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 621505 |
| MDR Report Key | 621505 |
| Date Received | 2005-07-01 |
| Date of Report | 2005-05-24 |
| Date of Event | 2005-05-10 |
| Report Date | 2005-05-24 |
| Date Reported to FDA | 2005-07-01 |
| Date Added to Maude | 2005-07-19 |
| 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 | CUSA |
| Generic Name | ULTRASONIC ASPIRATION SYSTEM |
| Product Code | LBK |
| Date Received | 2005-07-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 611152 |
| Manufacturer | VALLEYLAB |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-01 |