MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-24 for SLIMLINE EZ * 840-893 manufactured by Lumenis, Inc..
[1184890]
For lithotripsy precedure, the laser fiber device was attached to the laser generator, and fed through ureteroscope. The end of the fiber device was placed near the stone, and activated. During the procedure, it was seen on the monitor that the fiber device was not working, i. E. There was no laser pulse being applied to the stone. The device was removed for inspection, and it was noted that a 3 cm piece of the end of the fiber device had broken off and remained in the patient. The broken piece was retrieved with a grasper. There was no known injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1487221 |
| MDR Report Key | 1487221 |
| Date Received | 2009-09-24 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-08-14 |
| Report Date | 2009-09-22 |
| Date Reported to FDA | 2009-09-24 |
| Date Added to Maude | 2009-09-30 |
| 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 | SLIMLINE EZ |
| Generic Name | FIBER, LASER |
| Product Code | LNK |
| Date Received | 2009-09-24 |
| Model Number | * |
| Catalog Number | 840-893 |
| Lot Number | 86500209 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 2400 CODENSA STREET SANTA CLARA CA 95051090 US 95051 0901 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-24 |