MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-14 for BOSTON SCIENTIFIC CORP. DUO TOME SIDE LITE 840-846 manufactured by .
[1202601]
Broken laser delivers device caused burn to hand of operator during cysto electro vaporization of prostate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010730 |
| MDR Report Key | 1362056 |
| Date Received | 2009-04-14 |
| Date of Report | 2009-04-06 |
| Date of Event | 2009-04-03 |
| Date Added to Maude | 2009-04-27 |
| 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 | 0 |
| Health Professional | 0 |
| 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 CORP. |
| Generic Name | DUO TOME SIDE LITE 550 |
| Product Code | LNK |
| Date Received | 2009-04-14 |
| Model Number | DUO TOME SIDE LITE |
| Catalog Number | 840-846 |
| Lot Number | 70960208 |
| Device Expiration Date | 2013-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-14 |