MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-23 for * KTP 532 10-0612 - FIBREOPTIC manufactured by Laserscope.
[114858]
The physician was attempting to ablate an endometrium using a laserscope endostat fibreoptic delivery system. When the laser was engaged, a large flash of light was seen. It should have been concentrated light at the tip of the fibre. The surgeon noticed several burn marks on the uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 199930 |
| MDR Report Key | 199930 |
| Date Received | 1998-11-23 |
| Date of Report | 1998-11-23 |
| Date of Event | 1998-11-13 |
| Date Facility Aware | 1998-11-13 |
| Report Date | 1998-11-23 |
| Date Reported to FDA | 1998-11-23 |
| Date Added to Maude | 1998-12-04 |
| 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 | * |
| Generic Name | LASER YAG |
| Product Code | LLW |
| Date Received | 1998-11-23 |
| Model Number | KTP 532 |
| Catalog Number | 10-0612 - FIBREOPTIC |
| Lot Number | 10-0612-838 |
| ID Number | GOOD TILL 9-2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 194221 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-11-23 |