MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-29 for LASERSCOPE GREENLIGHT HPS BPH FIBEROPTIC 10-2090 manufactured by Laserscope.
[17017159]
Midway through a greenlight laser procedure in the operating room, the surgeon stated the fiber for the laser had broken and said he needed a new one. The "broken" fiber was removed from the surgical field and saved, along with the plastic card and package that the fiber came in, labeling it with a patient sticker. The case was finished, and the surgeon asked for more information r. E. The broken fiber. He stated that the fiber had broken in the patient, and that the patient "would pee out" the piece remaining inside [the patient's bladder]. Dates of use: 2008. Diagnosis or reason for use: benign prostatic hyper-trophy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005177 |
| MDR Report Key | 990685 |
| Date Received | 2008-01-29 |
| Date of Report | 2008-01-29 |
| Date of Event | 2008-01-28 |
| 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 FIBEROPTIC |
| Generic Name | GREENLIGHT LASER FIBER |
| Product Code | LNK |
| Date Received | 2008-01-29 |
| Model Number | 10-2090 |
| Catalog Number | 10-2090 |
| Lot Number | 10-2090-737 R |
| ID Number | * |
| Device Expiration Date | 2008-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 961594 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-29 |