MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-20 for * UNK manufactured by Applied Medical.
[597626]
While performing a cystoscopy, ureteroscopy, and laser lithotripsy, the tip of the laser broke off in the ureter. Physician successfully removed the tip with no resulting extended harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042640 |
| MDR Report Key | 842288 |
| Date Received | 2007-04-20 |
| Date of Report | 2007-04-20 |
| Date of Event | 2007-04-11 |
| Date Added to Maude | 2007-05-01 |
| 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 |
| 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 | * |
| Generic Name | LASER LITHOTRIPSER |
| Product Code | LNK |
| Date Received | 2007-04-20 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 829500 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | * RANCHO SANTA MARGARITA CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-20 |