MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-20 for ACCUFLEX MOO68408020 840802 manufactured by Boston Scientific Corp..
[691080]
Laser fiber fired at point other than the tip during a lithotripsy of the kidney. During case by dr, urology. Fiber was 200 micron fiber used with lumines holmium laser. Date of use: 2007. Diagnosis or reason for use: kidney stone. Event abated after use stopped: yes. Event reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003835 |
| MDR Report Key | 917862 |
| Date Received | 2007-09-20 |
| Date of Report | 2007-09-20 |
| Date of Event | 2007-09-13 |
| Date Added to Maude | 2007-09-28 |
| 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 | ACCUFLEX |
| Generic Name | HOLMIUM LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-09-20 |
| Returned To Mfg | 2007-09-20 |
| Model Number | MOO68408020 |
| Catalog Number | 840802 |
| Lot Number | TRF1067A |
| Device Expiration Date | 2010-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 891916 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA 017601537 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-20 |