MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-28 for GREENLIGHT PVP * manufactured by Laserscope.
[19491473]
At 1154, greenlight pvp was started. Shortly after handing first fiber to the physician, he asked for the second one. About 1210, there was a bright green light in the room. A few seconds later, the physician noted: "laser machine was firing outside of the patient, without me pressing the the foot pedal while i was draining the bladder! " immediately turned the equipment off; the physician took off his glove and noted left index finger was white crusty. Notified manufacturer. Procedure converted to turp (transurethral resection of the prostate) for the safety of patient. Follow-up reveals: laserscope evaluated the laser and was unable to duplicate the problem. They exchanged the footswitch and sent the original for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 831810 |
| MDR Report Key | 831810 |
| Date Received | 2007-02-28 |
| Date of Report | 2007-02-28 |
| Date of Event | 2006-12-28 |
| Report Date | 2007-02-28 |
| Date Reported to FDA | 2007-02-28 |
| Date Added to Maude | 2007-03-29 |
| 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 | GREENLIGHT PVP |
| Generic Name | LASER, SURGICAL |
| Product Code | LNK |
| Date Received | 2007-02-28 |
| Returned To Mfg | 2007-01-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 819151 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | 3070 ORCHARD DRIVE SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-28 |