MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-31 for LASERSCOPE LASER KTP-532 manufactured by Laserscope.
[18165986]
During bronchoscopy, laser treatment of tumor attempted. Fire erupted in airway after initial firing of laserscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29852 |
| MDR Report Key | 29852 |
| Date Received | 1996-01-31 |
| Date of Report | 1996-01-24 |
| Date of Event | 1996-01-19 |
| Report Date | 1996-01-24 |
| Date Added to Maude | 1996-02-12 |
| 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 |
| 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 | LASERSCOPE LASER |
| Generic Name | LASER |
| Product Code | LLO |
| Date Received | 1996-01-31 |
| Model Number | KTP-532 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30933 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | 3052 ORCHARD SAN JOSE CA 951342011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-01-31 |