MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-13 for CO2 LASER UP 5000C manufactured by Coherent.
[13330]
Pt sustained first degree burns, with a small area of second degree burn, which required medical intervention, as a result of a fire started by a laser. Surgeon was performing a beam alignment before surgical procedure, in accordance with the recommendations set forth in the operating manual. Laser was set at 10 mj - 6w in cw mode. A 0. 2 mm handpiece was used. When surgeon activated foot pedal, the laser beam immediately passed through the tongue depressor used for alignment and ignited a small fire on surgical drapes. Surgeon described the energy output from the laser as unusual. Fire was quickly extinguished by or personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24192 |
| MDR Report Key | 24192 |
| Date Received | 1995-07-13 |
| Date of Report | 1995-02-20 |
| Date of Event | 1995-02-08 |
| Date Facility Aware | 1995-02-08 |
| Report Date | 1995-02-20 |
| Date Reported to Mfgr | 1995-02-21 |
| Date Added to Maude | 1995-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO2 LASER |
| Generic Name | LASER |
| Product Code | EWG |
| Date Received | 1995-07-13 |
| Model Number | UP 5000C |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | UNIT 51318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 24551 |
| Manufacturer | COHERENT |
| Manufacturer Address | PALO ALTO CA 94303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-13 |