MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-30 for LASERSCOPE GREENLIGHT HPS BPH FIBER 10-2090 manufactured by Laserscope.
[18910973]
Set at 120 vapor and 20 coag with only 1732g and 16 sec. The laser disintegrated, and pieces of fibers broke off in patients bladder. Had to be retrieved by md. Dates of use: 2008. Diagnosis or reason for use: bph.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005208 |
| MDR Report Key | 991127 |
| Date Received | 2008-01-30 |
| Date of Report | 2008-01-30 |
| Date of Event | 2008-01-26 |
| Date Added to Maude | 2008-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASERSCOPE GREENLIGHT HPS BPH FIBER |
| Generic Name | GREENLIGHT LASER FIBER |
| Product Code | LNK |
| Date Received | 2008-01-30 |
| Model Number | 10-2090 |
| Catalog Number | 10-2090 |
| Lot Number | 10-2090-737R |
| Device Expiration Date | 2008-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960778 |
| Manufacturer | LASERSCOPE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-30 |