MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-02 for CUSA EXCEL CONSOLE CUSAEXCEL manufactured by Valleylab.
[558482]
The physician has alleged that the unit activated the ultrasonics on its own. As a result, the pt sustained a burn of the dura.
Patient Sequence No: 1, Text Type: D, B5
[7956689]
The mfr has been notified of the reported complaint. The group leader of software support visited the user facility and tested each of the 4 hand pieces in the presence of the nurse who reported the incident. Each hand piece was observed without activation for 5 minutes, and then activated to ensure its proper function for 2 minutes. None of the hand pieces self activated during the testing. Subsequently, the nurse at the user facility acknowledged that the equipment is functioning properly. Based on the reported info and the onsite eval of the equipment, we are unable to confirm or determine the root cause of the alleged incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003418325-2007-00003 |
| MDR Report Key | 836008 |
| Date Received | 2007-04-02 |
| Date of Report | 2007-03-30 |
| Date Facility Aware | 2007-01-25 |
| Report Date | 2007-02-27 |
| Date Mfgr Received | 2007-01-25 |
| Date Added to Maude | 2007-04-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Manufacturer Contact | LINDA GOODSTEIN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | VALLEYLAB |
| Manufacturer Street | 5920 LONGBOW DRIVE BLDG 1, SERVICE DEPT |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSA EXCEL CONSOLE |
| Product Code | LBK |
| Date Received | 2007-04-02 |
| Catalog Number | CUSAEXCEL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 823300 |
| Manufacturer | VALLEYLAB |
| Manufacturer Address | BOULDER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-02 |