MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-21 for GREENLIGHT ADDSTAT 0010-2090 manufactured by American Medical Systems, Innovation Center - Silicon Valley.
[16641669]
It was reported by the customer that on (b)(6) 2010 the fiber lost aiming beam at 0 joules. The device was not returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2010-00839 |
| MDR Report Key | 1889761 |
| Report Source | 05 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-09-24 |
| Date of Event | 2010-07-23 |
| Date Mfgr Received | 2010-09-24 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2011-03-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. BONNIE SCHRIER |
| Manufacturer Street | 3070 ORCHARD DR. |
| Manufacturer City | SAN JOSE CA 951342011 |
| Manufacturer Country | US |
| Manufacturer Postal | 951342011 |
| Manufacturer Phone | 4084563326 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENLIGHT ADDSTAT |
| Generic Name | SURGICAL FIBER |
| Product Code | EWG |
| Date Received | 2010-10-21 |
| Model Number | NA |
| Catalog Number | 0010-2090 |
| Lot Number | 012H |
| Device Expiration Date | 2012-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY |
| Manufacturer Address | SAN JOSE CA 95134201 US 95134 2011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-21 |