MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-13 for LUMENIS HOLMIUM 100W LITHOTRAYPSY SLIMELINE 365 3616307 manufactured by Boston Scientific.
[697946]
Deflecting mechanism to flexible ureteroscope stopped working in the case as noted by surgeon. The laser fiber was broken. Surgeon stated the scope stopped working due to damage probably from the broken laser fiber. Intervention to retrieve two -2- pieces of retained broken laser fiber inside pt's left ureter. Dates of use: seven days. Diagnosis or reason for use: kidney stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003772 |
| MDR Report Key | 914496 |
| Date Received | 2007-09-13 |
| Date of Report | 2007-09-13 |
| Date of Event | 2007-09-12 |
| Date Added to Maude | 2007-09-25 |
| 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 | LUMENIS HOLMIUM 100W LITHOTRAYPSY |
| Generic Name | VERSA PULSE SLIMLINE FIBER DELIVERY DEVICE |
| Product Code | LNK |
| Date Received | 2007-09-13 |
| Model Number | SLIMELINE 365 |
| Catalog Number | 3616307 |
| Lot Number | 53610307 |
| ID Number | STERILIZED AND |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 889087 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1945 | 1. Deathisabilit | 2007-09-13 |