MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-06 for * manufactured by Laserscope.
[755248]
Laserscope fiber tip broke off during laser prostatectomy inside patient bladder. Doctor removed the broken tip with grasping forceps while visualizing with camera.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 975902 |
| MDR Report Key | 975902 |
| Date Received | 2007-12-06 |
| Date of Report | 2007-12-06 |
| Date of Event | 2007-11-30 |
| Report Date | 2007-12-06 |
| Date Reported to FDA | 2007-12-06 |
| Date Added to Maude | 2008-01-09 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | FIBER, LASER |
| Product Code | LNK |
| Date Received | 2007-12-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 10-2090-731G |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 943919 |
| Manufacturer | LASERSCOPE |
| Manufacturer Address | 3070 ORCHARD DRIVE SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-06 |