MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-21 for LASERSCOPE 7107 * manufactured by Laserscope.
[21697694]
While using the green light laser during a pvp (photoselective vaporization of the prostate), the wattage decreased from 80 watts to 65 watts automatically. Physician notified, and the case continued with the lower wattage. Error code 44 on screen of machine. Company notified and bio-med aware. Maintenance from laserscope to come in to service the laser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 907525 |
| MDR Report Key | 907525 |
| Date Received | 2007-08-21 |
| Date of Report | 2007-08-21 |
| Date of Event | 2007-08-08 |
| Report Date | 2007-08-21 |
| Date Reported to FDA | 2007-08-21 |
| Date Added to Maude | 2007-09-06 |
| 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 |
| Generic Name | LASER, KTP, UROLOGIC |
| Product Code | LNK |
| Date Received | 2007-08-21 |
| Model Number | 7107 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 882061 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | 3070 ORCHARD DRIVE SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-21 |