MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-19 for HOLMIUM 365 * manufactured by Boston Scientific Corp..
[19490382]
When using holmium laser fiber, the 365 fiber broke in patient's ureter. The doctor was aware of incident and retrieval was attempted, however the doctor was unable to find the piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 844039 |
| MDR Report Key | 844039 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-04-19 |
| Date of Event | 2007-03-12 |
| Report Date | 2007-04-19 |
| Date Reported to FDA | 2007-04-19 |
| Date Added to Maude | 2007-05-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLMIUM |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-04-19 |
| Model Number | 365 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 831218 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 1 BOSTON SCIENTIFIC PLACE NATICK MA 01760 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-19 |