MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-04 for AMS 10-2090 manufactured by American Medical Systems.
[962492]
While performing transurethral destruction of prostate using the niagra greenlight laser, the tip of the laser fiber broke off inside of pt. Dr. Recovered tip of fiber before awaking pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008872 |
| MDR Report Key | 1220911 |
| Date Received | 2008-11-04 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-10-20 |
| Date Added to Maude | 2008-11-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS |
| Generic Name | GREENLIGHT HPS BPH FIBER OPTIC (LASER) |
| Product Code | LNK |
| Date Received | 2008-11-04 |
| Returned To Mfg | 2008-10-20 |
| Catalog Number | 10-2090 |
| Lot Number | 10-2090-831D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1273740 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | INNOVATION CENTER SILICON VALL 3070 ORCHARD DR. SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-11-04 |