MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-14 for QUANTA BAREFIBER * manufactured by Fibertech Usa, Inc..
[678009]
There was an equipment failure with two laser fibers. The fibers broke when they were being used in the ureteroscopes, while in use on the patient. The fibers that broke in the ureteroscope where removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 887809 |
| MDR Report Key | 887809 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-14 |
| Date of Event | 2007-05-30 |
| Report Date | 2007-06-14 |
| Date Reported to FDA | 2007-06-14 |
| Date Added to Maude | 2007-08-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | QUANTA BAREFIBER |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-06-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 0603024 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 865304 |
| Manufacturer | FIBERTECH USA, INC. |
| Manufacturer Address | 4111 EAST VALLEY AUTO DRIVE SUITE 104 MESA AZ 85206 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-14 |