MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-10 for KATENA K3-2398 manufactured by Katena Products Inc.
[4626653]
Outpatient in for cataract repair. Surgeon used chopper during procedure and when the instrument was removed, an 1. 5mm metal tip was missing from the instrument. Instrument did not come in contact with any hard tissue or surfaces during the procedure. This required extensive direct visualization of the area and an x-ray to rule out the presence of a foreign body within the ocular cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037466 |
| MDR Report Key | 3964825 |
| Date Received | 2014-07-10 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-06-04 |
| Date Added to Maude | 2014-07-30 |
| 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 | KATENA |
| Generic Name | CHOPPER |
| Product Code | HNZ |
| Date Received | 2014-07-10 |
| Model Number | K3-2398 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS INC |
| Manufacturer Address | 4 STEWART CT DENVILLE NJ 07834 US 07834 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-10 |