MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-04-05 for NOVUS 2000 * 0613-001-01 manufactured by Lumenis, Inc. (formerly Coherent).
[15678308]
Pt received a full-thickness retinal burn when the physician, who was accustomed to treating at a setting of 100 mw, did not realize that the power setting retained in memory from the prior case (1000 mw) contained a fourth digit. Other treatment parameters were 100 micron spot size, 0. 1 second duration. The physician performed a single parafoveal test shot (off-center) at the 1000 mw and, immediately realizing the high setting, suspended the treatment. The pt is being followed for the retinal burn. Per the physician, pre-incident visual acuity was nearly 20-20 based on standard snellen test; post-incident snellen test per the phhysician appears at this time not to have changed from baseline. Visual field test is pending within the next month and will indicate the presence and severity of any decrement to peripheral vision. "laser power set too high (1000mw instead of 100mw) for the required rertinal photocoagulation treatment. This error arose out of laser having been used by a previous operator at much higher power than is usual. Power settings remained in laser software memory from previous treatment despite shutting down the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2005-00003 |
| MDR Report Key | 588062 |
| Report Source | 00 |
| Date Received | 2005-04-05 |
| Date of Report | 2005-04-01 |
| Date of Event | 2005-02-07 |
| Date Facility Aware | 2005-02-07 |
| Report Date | 2005-03-22 |
| Date Mfgr Received | 2005-03-22 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 2005-04-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANIS ARRIGONI |
| Manufacturer Street | 2400 CONDENSA STREET |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4087643208 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVUS 2000 |
| Generic Name | OPHTHALMIC LASER |
| Product Code | HQB |
| Date Received | 2005-04-05 |
| Model Number | * |
| Catalog Number | 0613-001-01 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 577910 |
| Manufacturer | LUMENIS, INC. (FORMERLY COHERENT) |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | NOVUS 2000 |
| Baseline Generic Name | OPHTHALMIC LASER |
| Baseline Model No | * |
| Baseline Catalog No | 0613-001-01 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-05 |