MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-23 for LASER PERIPHERAL RBLF-200 manufactured by Laser Peripherals.
[3463080]
The pt was admitted to the hosp to undergo cystoscopy, right retrograde pyelogram, right ureteroscopic laser lithotripsy and placement of a right ureteral stent. During the laser lithotripsy, a very small piece (200 micron) of laser fiber tip broke off into the right renal pelvis. Several basket attempts were made to retrieve the laser fragment, but they were unsuccessful. The other procedures were completed uneventfully and the pt was discharged with a good prognosis. The physician felt that this fragment piece should pose no future harm to the pt and may be able to pass on its own. The pt returned for f/u 2 weeks after the procedure and was doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030328 |
| MDR Report Key | 3136706 |
| Date Received | 2013-05-23 |
| Date of Report | 2013-05-23 |
| Date of Event | 2013-04-23 |
| Date Added to Maude | 2013-05-31 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASER PERIPHERAL |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2013-05-23 |
| Returned To Mfg | 2013-04-24 |
| Catalog Number | RBLF-200 |
| Lot Number | LP-200 |
| Device Expiration Date | 2015-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LASER PERIPHERALS |
| Manufacturer Address | GOLDEN VALLEY MN 55427 US 55427 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-23 |