MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-18 for AMS-HPS FIBEROPTICS-BPH FIBEROPTIC GREEN LIGHT HPS 10-2090 manufactured by .
[1271467]
During greenlight procedure, the tip broke off of the fiber inside the patient bladder. Surgeon was able to retrieve broken off tip. X-rays taken to ensure no other piece was in bladder and none was found. Diagnosis or reason for use: obstructive lower urinary tract symptoms status post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011587 |
| MDR Report Key | 1404737 |
| Date Received | 2009-06-18 |
| Date of Report | 2009-06-18 |
| Date of Event | 2009-06-16 |
| Date Added to Maude | 2009-06-24 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS-HPS FIBEROPTICS-BPH FIBEROPTIC GREEN LIGHT HPS |
| Generic Name | NONE |
| Product Code | OEL |
| Date Received | 2009-06-18 |
| Returned To Mfg | 2009-06-18 |
| Model Number | 10-2090 |
| Lot Number | 10-2090-910W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-06-18 |