MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-03 for MINVASIVE LASER FIBER manufactured by .
[18511900]
Surgeon doing laser turp in the or, heard pop noise, looked at the tip of the laser fiber and discovered it had shattered. Surgeon was able to retrieve the fragment pieces with a gripper. Laser was checked out with biomed before case started.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006136 |
| MDR Report Key | 1025038 |
| Date Received | 2008-04-03 |
| Date of Report | 2008-04-03 |
| Date of Event | 2008-01-03 |
| Date Added to Maude | 2008-04-11 |
| 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 | MINVASIVE LASER FIBER |
| Generic Name | NONE |
| Product Code | LNK |
| Date Received | 2008-04-03 |
| Lot Number | 750P-1272 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-03 |