MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-21 for SURGICAL LASER GRENNLIGHT PVP * manufactured by Laserscope.
[17730737]
Could not insert fiber in laser aperture thereby rendering laser inoperable. Patient was not able to have procedure and had to be rescheduled a month later. Greenlight pvp laser rented from a co who also provides accessories for operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 836879 |
| MDR Report Key | 836879 |
| Date Received | 2007-03-21 |
| Date of Report | 2007-03-21 |
| Date of Event | 2007-01-29 |
| Report Date | 2007-03-21 |
| Date Reported to FDA | 2007-03-21 |
| Date Added to Maude | 2007-04-13 |
| 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 | SURGICAL LASER |
| Generic Name | LASER, PROSTATE |
| Product Code | LNK |
| Date Received | 2007-03-21 |
| Model Number | GRENNLIGHT PVP |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 2 YRS |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 824176 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | 3070 ORCHARD DRIVE SAN JOSE, CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-21 |