MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-07 for HOLMIUM LASER FIBER 840-892 manufactured by Boston Scientific.
[811857]
Holmium laser fiber failed. Technician stated laser fiber connection was not crimped properly by the manufacturer. Fiber removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006186 |
| MDR Report Key | 1027043 |
| Date Received | 2008-04-07 |
| Date of Report | 2008-04-07 |
| Date of Event | 2008-03-26 |
| Date Added to Maude | 2008-04-17 |
| 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 | HOLMIUM LASER FIBER |
| Generic Name | HOLMIUM LASER FIBER |
| Product Code | LNK |
| Date Received | 2008-04-07 |
| Model Number | 840-892 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 994866 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | NATICK MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-04-07 |