MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-10-06 for NOVUS VERDI * manufactured by Lumenis, Inc..
[525422]
The details were provided by the enduser biomedical engineer (initial reporter). Per the physician, during system set-up, the physician received a prompt to re-start the system; the physician restarted the system and the system successfully completed start-up. Per the physician, when the physician switched from stand-by to ready, the system fired without footpedal depressed. Per the initial reporter, the physician received a flashback and was evaluated by another md. Details requested by lumenis and not provided as of 10/06/2006. The system was evaluated by the lumenis ce, who could not duplicate the reported problem and also found no safety related problems with the device. Per customer request, the system will be sent for additional evaluation at the lumenis slc service depot.
Patient Sequence No: 1, Text Type: D, B5
[7792050]
Lumenis requested details regarding the status of the physician following the incident and any medical intervention. This information is pending as of 10/06/2006. Lumenis service evaluated the novus verdi system, and the customer engineer could not duplicate the reported problem. The ce also was not able to find any safety-related problem with the device. On 9/21/2006 arrangements were made to ship the device to the lumenis service depot for additional evaluation. A follow-up report will be filed with any additional findings and root cause analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720381-2006-00003 |
| MDR Report Key | 768910 |
| Report Source | 00 |
| Date Received | 2006-10-06 |
| Date of Report | 2006-10-06 |
| Date of Event | 2006-09-08 |
| Date Mfgr Received | 2006-09-08 |
| Date Added to Maude | 2006-10-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANIS ARRIGONI |
| Manufacturer Street | 2400 CONDESA ST. |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4087643208 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | SALT LAKE CITY UT * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVUS VERDI |
| Generic Name | ND: YAG PHOTOCOAGULATOR |
| Product Code | HQB |
| Date Received | 2006-10-06 |
| Model Number | * |
| Catalog Number | VERDI |
| Lot Number | * |
| ID Number | INSTALL 3/16/2001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 756765 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-06 |