MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-30 for RITLENG PROBE UNK manufactured by Fci Ophthalmics.
[1448715]
During surgery for bilateral probe and irrigation with silicone intubation of lacrimal ducts, the physician noticed that the lacrimal duct instrument probe tip was missing. He had inserted the tube on the right side and noticed that the instrument tip was missing while inserting the tube on the left side. While in the pacu, an x-ray was taken and the physician and anesthesiologist assessed that the instrument tip was in the pt's left nasal area. The pt was returned to the operating room for possible retrieval / removal of the broken instrument prove tip. The physician performed exploratore left nasal endoscopic surgery without identifying the foreign body. Fluoroscopy of the head area performed in the operating room also without identification of foreign body. Anesthesiologist examined contents of suction cannister. No operative complications - pt tolerated procedure well.
Patient Sequence No: 1, Text Type: D, B5
[8506741]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1595322 |
| MDR Report Key | 1595322 |
| Report Source | 06 |
| Date Received | 2010-01-30 |
| Date of Report | 2009-11-20 |
| Date of Event | 2009-11-13 |
| Date Facility Aware | 2009-11-13 |
| Report Date | 2009-11-20 |
| Date Reported to Mfgr | 2009-11-20 |
| Date Mfgr Received | 2009-11-30 |
| Date Added to Maude | 2010-02-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE BOHSACK |
| Manufacturer Street | PO BOX 465 |
| Manufacturer City | MARSHFIELD HILLS MA 02051 |
| Manufacturer Country | US |
| Manufacturer Postal | 02051 |
| Manufacturer Phone | 7818269060 |
| Manufacturer G1 | FCI (FRANCE) MANUFACTURER |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITLENG PROBE |
| Generic Name | RITLENG PROBE |
| Product Code | HNL |
| Date Received | 2010-01-30 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | FCI SI-1460U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FCI OPHTHALMICS |
| Manufacturer Address | P.O. BOX 465 MARSHFIELD HILLS MA 02051 US 02051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-01-30 |