MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2003-05-06 for 1041S AA2389700 manufactured by Lumenis (israel).
[324963]
During the setup of the 1041s system for a gynecological procedure, the laser beam (which was pointed in the direction of the patient), hit the drape covering the patient, which caught fire. There were no injuries to the patient or staff during this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914019-2003-00012 |
| MDR Report Key | 458811 |
| Report Source | 00,06 |
| Date Received | 2003-05-06 |
| Date of Report | 2003-05-06 |
| Date of Event | 2003-04-09 |
| Date Facility Aware | 2003-04-09 |
| Date Mfgr Received | 2003-04-09 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2003-05-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE WLSBAR |
| Manufacturer Street | 2400 CONDENSA STREET |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4087643221 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1041S |
| Generic Name | SURGICAL LASERS |
| Product Code | LLW |
| Date Received | 2003-05-06 |
| Model Number | 1041S |
| Catalog Number | AA2389700 |
| Lot Number | * |
| ID Number | K923605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 447773 |
| Manufacturer | LUMENIS (ISRAEL) |
| Manufacturer Address | P.O. BOX 240 YOKNEAM IS 20692 |
| Baseline Brand Name | 1041S |
| Baseline Generic Name | SURGICAL LASERS |
| Baseline Model No | 1041S |
| Baseline Catalog No | AA2389700 |
| Baseline ID | K923605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-05-06 |