MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-06-22 for NOVUS 2000 0613-001-01 manufactured by Cohernt Medical.
[15033933]
The laser was set to power 3000, duration 0. 2, repeat 3. 3 when machine was put on standby, the repeat setting had gone to 2. 8 without touching the setting control. Procedure type: vitrectomy, scleral buckle performed by an md. They used third party service who determined that a fracture fiberoptic wire caused the problem. The wire was replaced before the laser was used again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914019-2005-00001 |
| MDR Report Key | 616435 |
| Report Source | 06 |
| Date Received | 2005-06-22 |
| Date of Report | 2005-06-22 |
| Date of Event | 2005-03-01 |
| Date Facility Aware | 2005-03-01 |
| Report Date | 2005-06-02 |
| Date Reported to FDA | 2005-06-22 |
| Date Mfgr Received | 2005-06-02 |
| Device Manufacturer Date | 1991-01-01 |
| Date Added to Maude | 2005-06-24 |
| 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 | 0 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVUS 2000 |
| Generic Name | OPHTHALMIC LASER |
| Product Code | HQB |
| Date Received | 2005-06-22 |
| Model Number | 2000 |
| Catalog Number | 0613-001-01 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 606166 |
| Manufacturer | COHERNT MEDICAL |
| Manufacturer Address | 3270 W. BAYSHORE ROAD PALO ALTA CA * US |
| Baseline Brand Name | NOVUS 2000 |
| Baseline Generic Name | OPHTHALMIC LASER |
| Baseline Model No | 2000 |
| Baseline Catalog No | 0613-001-01 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-22 |