MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-01 for RITLENG PROBE S1.1460U manufactured by Fci Ophthalmics.
[2008238]
Tip of probe broke off and discovered missing immediately by surgeon upon removal from right lacrimal duct of (b)(6) male with right eye nasolacrimal duct obstruction. While the ent surgeon was probing the right lacrimal duct with the intention of unblocking the duct and placing a stent, the tip of the probe broke off. This was discovered when the probe was withdrawn by the surgeon. An x-ray was taken which confirmed the presence of a broken tip. Decision was made to abort the procedure and the pt was sent to a specialist at an eye clinic and eventually had the piece removed. Probe is ritleng probe s1. (b)(4) -mfr fci ophthalmics-. Dates of use: (b)(6) 2001 -- (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020861 |
| MDR Report Key | 2115423 |
| Date Received | 2011-06-01 |
| Date of Report | 2011-06-01 |
| Date of Event | 2011-05-04 |
| Date Added to Maude | 2011-06-13 |
| 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 | RITLENG PROBE S1.1460U |
| Generic Name | RITLENG PROBE |
| Product Code | HNL |
| Date Received | 2011-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FCI OPHTHALMICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-06-01 |