MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-10 for BOSTON SCIENTIFIC 840-846 manufactured by Boston Scientific.
[1539321]
Pt complained of prostatitis & urinary retention. Pt having a laser tur done using laser fibers through a laser cystoscope. Using 80 watts the bladder neck and median bar was lased. Using 100 watts the lateral lobes were then lased. The first two fibers were defective and appropriate therapy was not completed until the third fiber was used (from a different lot). Black sediment and spots of black metallic noted with the defective fibers. The holmium laser was being used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016335 |
| MDR Report Key | 1724935 |
| Date Received | 2010-06-10 |
| Date of Report | 2010-06-10 |
| Date of Event | 2010-05-26 |
| Date Added to Maude | 2010-06-17 |
| 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 | BOSTON SCIENTIFIC |
| Generic Name | DUOTOME LASER FIBER |
| Product Code | LNK |
| Date Received | 2010-06-10 |
| Returned To Mfg | 2010-06-07 |
| Catalog Number | 840-846 |
| Lot Number | 99591009 |
| Device Expiration Date | 2014-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-10 |