MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-23 for * manufactured by Trimedyne, Inc..
[19529384]
Patient had left ureteral stone. Surgeon was preparing to use the holmium laser to crush the stone when he noticed something strange in the ureter. He removed the laser fiber and looked for any damage. Damage was not immediately noted. Upon reinsertion of the ureteroscope, the surgeon identified a foreign object inside the ureter and used grasping forceps to remove the object. The object appeared to be part of the outer covering sheath. The laser fiber was immediately taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1373209 |
| MDR Report Key | 1373209 |
| Date Received | 2009-04-23 |
| Date of Report | 2009-04-23 |
| Date of Event | 2009-04-22 |
| Report Date | 2009-04-23 |
| Date Reported to FDA | 2009-04-23 |
| Date Added to Maude | 2009-05-05 |
| 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 |
| 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 | LASER FIBER |
| Product Code | LNK |
| Date Received | 2009-04-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIMEDYNE, INC. |
| Manufacturer Address | 25901 COMMERCENTER DRIVE LAKE FOREST CA 92630 US 92630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-23 |