MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-24 for AMS 10-2090 manufactured by American Medical Systems (ams).
[1637928]
Ams laser green light hps bph fiber optic laser tip broke off inside of pt while surgeon was performing photovaporization of the prostate. Visible glass fragments from laser tip were then retrieved by the surgeon. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016522 |
| MDR Report Key | 1741365 |
| Date Received | 2010-06-24 |
| Date of Report | 2010-06-22 |
| Date of Event | 2010-06-14 |
| Date Added to Maude | 2010-07-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 LASER PROBE |
| Product Code | LNK |
| Date Received | 2010-06-24 |
| Returned To Mfg | 2010-06-14 |
| Model Number | 10-2090 |
| Catalog Number | 10-2090 |
| Lot Number | 10-2090-011H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (AMS) |
| Manufacturer Address | MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-24 |