MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-04 for HOLMIUM BARE SINGLE-USE LASER ACCESORY HB-200 manufactured by Laser Peripherals.
[637908]
Approximately one cm of the holmium laser fiber tip broke off in the patient's bladder. The piece was retrieved by the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 846728 |
| MDR Report Key | 846728 |
| Date Received | 2007-05-04 |
| Date of Report | 2007-05-04 |
| Date of Event | 2007-03-20 |
| Report Date | 2007-05-04 |
| Date Reported to FDA | 2007-05-04 |
| Date Added to Maude | 2007-05-14 |
| 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 | HOLMIUM BARE SINGLE-USE LASER ACCESORY |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-05-04 |
| Model Number | HB-200 |
| Catalog Number | HB-200 |
| Lot Number | LP-414 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 833858 |
| Manufacturer | LASER PERIPHERALS |
| Manufacturer Address | 1000 BOONE AVE NORTH SUITE 300 GOLDEN VALLEY MN 55427 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-04 |