MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-21 for FCI-RITLENG HOOK S1-1480 NA manufactured by Fci-ophthalmics, Inc..
[161080]
Dr was doing tear duct probing when tip of hook broke off and fell into pt's nose.
Patient Sequence No: 1, Text Type: D, B5
[20693843]
Add'l info rec'd from mfr 2/18/00: please note that mfr does not consider this to be a reportable event. Mfr is still awaiting the return of the broken instrument from facility for examination and until mfr has it, mfr is not able to comment any more. Mfr must have the instrument and whatever pieces are available examined in the lab by fci quality control for possible mechanical, mfg and/or material defects. Following such examination and evaluation, a report will be issued stating both the facts as determined thereby and whatever corrective action is required, if any. If corrective action is required, the report will also state that it has been initiated and when it will be fully operative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017771 |
| MDR Report Key | 255662 |
| Date Received | 1999-12-21 |
| Date of Report | 1999-12-09 |
| Date of Event | 1999-12-07 |
| Date Added to Maude | 1999-12-27 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FCI-RITLENG HOOK |
| Generic Name | SURGICAL/INSTRUMENT USED FOR RETRIEVAL OF SURFACE FROM NASAL |
| Product Code | HNQ |
| Date Received | 1999-12-21 |
| Model Number | S1-1480 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 247562 |
| Manufacturer | FCI-OPHTHALMICS, INC. |
| Manufacturer Address | 76 PROSPECT ST. MARSHFIELD HILLS MA 02051 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-12-21 |