MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-14 for BOSTON SCIENTIFIC SIDELITE 550 LASER FIBER 840-846 manufactured by Boston Scientific.
[1340179]
After approx 20 minutes of fiber use, fiber malfunctioned. Laser fiber caught fire. Fiber removed immediately from service. No noted pt harm. Dose or amount: 2. 0 joules, frequency: rate 40, route: laser (prostate). Date of use: (b) (6) 2010. Event abated after use: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016343 |
| MDR Report Key | 1726650 |
| Date Received | 2010-06-14 |
| Date of Report | 2010-04-07 |
| Date of Event | 2010-04-07 |
| 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 |
| 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 SIDELITE 550 LASER FIBER |
| Generic Name | NONE |
| Product Code | LNK |
| Date Received | 2010-06-14 |
| Catalog Number | 840-846 |
| Lot Number | 84320109 |
| Device Expiration Date | 2013-12-01 |
| 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. Required No Informationntervention | 2010-06-14 |