MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-21 for HOLMIUM LASER 1210-VHP * manufactured by Trimedyne, Inc..
[973476]
Holmium laser was being used to break down a bladder stone. The 1,000um fiber was selected and inserted into the laser by the rn laser operator. The watts were increased to 80, and the pps was set to 13 as requested by the surgeon. The 1,000 micron laser fiber was introduced through a rigid cystoscope after visualization of the stone. When the surgeon was attempting to use the laser, it was noted that the laser was not putting out proper energy. The laser beam and aiming beam would not work. The laser was used for a total of 7 minutes. The nurse manager for or urology services was called and asked to come to the or suite. At that time the surgeon was asked if the rn laser operator could change the fiber and try a new one to see if the new fiber would work. The laser was placed on stand-by and a new fiber inserted by the manager. She was unable to adjust the aiming beam and the watts. She turned the laser off and back on. After turning it back on, the laser started smoking, was shut off, unplugged and moved out of the building. A fire extinguisher was used on the machine. No flame was seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1250983 |
| MDR Report Key | 1250983 |
| Date Received | 2008-11-21 |
| Date of Report | 2008-11-21 |
| Date of Event | 2008-11-21 |
| Report Date | 2008-11-21 |
| Date Reported to FDA | 2008-11-21 |
| Date Added to Maude | 2008-12-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HOLMIUM LASER |
| Generic Name | LASER, SURGICAL, HOLMIUM |
| Product Code | LNK |
| Date Received | 2008-11-21 |
| Model Number | 1210-VHP |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1304317 |
| Manufacturer | TRIMEDYNE, INC. |
| Manufacturer Address | 25901 COMMERCENTRE DRIVE LAKE FOREST CA 92630 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-21 |