MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-16 for MICRON 10853 manufactured by Micron.
[1084918]
Md using a 1000 micron peripheral fiber, holmium reuseable laser fiber to do procedure. Upon second entry with cystoscope the md passed the fiber through the scope and noted that het tip was broken. Fiber tip exchanged for another device, procedure continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012030 |
| MDR Report Key | 1418528 |
| Date Received | 2009-07-16 |
| Date of Report | 2009-07-16 |
| Date of Event | 2009-07-10 |
| Date Added to Maude | 2009-07-28 |
| 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 | MICRON |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2009-07-16 |
| Returned To Mfg | 2009-07-10 |
| Model Number | 10853 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRON |
| Manufacturer Address | 7620 NORTH HARTMAN LANE #184 TUCSON AZ 85743 US 85743 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-16 |