MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-29 for HOLMIUM LASER FIBER manufactured by .
[17023376]
During case - left stone retrieval with laser ureteroscopy - a clear piece of plastic broke off of the laser fiber tip. Dr - urologist- unable to retrieve the clear piece. Dr stated, he believed the issue to be clinically insignificant and would cause more harm than good to try to retrieve the very small piece. This product was supplied by a company, so unsure of brand they use. Dates of use: 2009. Diagnosis or reason for use: laser stone. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014149 |
| MDR Report Key | 1570727 |
| Date Received | 2009-12-29 |
| Date of Report | 2009-12-29 |
| Date of Event | 2009-11-25 |
| Date Added to Maude | 2010-01-08 |
| 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 | HOLMIUM LASER FIBER |
| Generic Name | NONE |
| Product Code | LNK |
| Date Received | 2009-12-29 |
| Lot Number | LP-544 |
| ID Number | REF NO. RBLF-200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-29 |