MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-11 for BOSTON SCIENTIFIC M0068408460 840-846 manufactured by Boston Scientific Corporation.
[19287017]
During cystoscopy while physician was lasering the prostate, the tip of the laser filter fell into the field. The tip was retrieved in its entirety using a grasper. A second laser filter was opened and the case continued. No lasting pt harm. Physician: md admitting diagnosis: benign prostatic hypertrophy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008951 |
| MDR Report Key | 1227023 |
| Date Received | 2008-11-11 |
| Date of Report | 2008-11-11 |
| Date of Event | 2008-10-24 |
| Date Added to Maude | 2008-11-20 |
| 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 | BOSTON SCIENTIFIC |
| Generic Name | DUO TOME SIDE LITE 550 |
| Product Code | LNK |
| Date Received | 2008-11-11 |
| Model Number | M0068408460 |
| Catalog Number | 840-846 |
| Lot Number | 72000308 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1283257 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | ONE BOSTON SCIENTIFIC WAY NATICK MA 017601537 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-11-11 |