MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-15 for ACCUFLEX UPN M0068408040 * manufactured by Boston Scientific Corp. (urology).
[933339]
The tip of the holmium laser fiber (boston scientific, accuflex) broke off as the surgeon was lasering the stone. The tip was retrieved in the stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1179623 |
| MDR Report Key | 1179623 |
| Date Received | 2008-09-15 |
| Date of Report | 2008-09-15 |
| Date of Event | 2008-09-04 |
| Report Date | 2008-09-15 |
| Date Reported to FDA | 2008-09-15 |
| Date Added to Maude | 2008-10-01 |
| 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 | ACCUFLEX |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2008-09-15 |
| Model Number | UPN M0068408040 |
| Catalog Number | * |
| Lot Number | TRF 036F |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1208584 |
| Manufacturer | BOSTON SCIENTIFIC CORP. (UROLOGY) |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-15 |