MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-04-24 for CHANG PHACO CHOPPER K3-2369 manufactured by Katena Products, Inc..
[1495797]
User facility voluntary report dated (b) (4) 2010; stated: "during cataract procedure on right eye, the physician noticed the microtip of the phaco chopper missing. The right eye was irrigated continuously and the procedure was completed. The physician was unable to visualize the tip with ophthalmoscope. An x-ray was done and the tip was not seen. "
Patient Sequence No: 1, Text Type: D, B5
[8465297]
Received page 1 only of user facility voluntary report (form 3500) dated (b) (4) 2010 via postal service on 03/25/2010. Of user facility voluntary report (3500) indicated device available for evaluation. Manufacturer contacted the user facility on several occasions, left messages for the risk manager, and user facility never returned calls or forwarded the subject device for manufacturer's evaluation. Without having the actual subject device available for evaluation, or the ability to discuss the event with the user facility and/or user; the manufacturers evaluation was limited to the review of the same device currently held in the manufacturer's controlled finished goods inventory and a review of the device history records and field use history. Magnified visual examination of devices in the manufacturers controlled inventory, found no anomalies and confirmed all units are within specified tolerances. Device history records were also confirmed to be in order no anomalies. Based on this, no final conclusions can be drawn concerning the reported event. (b) (4). (b) (4). The reporter does want their identity disclosed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242450-2010-00002 |
| MDR Report Key | 1673408 |
| Report Source | 06 |
| Date Received | 2010-04-24 |
| Date of Report | 2010-03-22 |
| Date of Event | 2010-02-25 |
| Date Mfgr Received | 2010-03-25 |
| Date Added to Maude | 2010-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 4 STEWART COURT |
| Manufacturer City | DENVILLE NJ 07834 |
| Manufacturer Country | US |
| Manufacturer Postal | 07834 |
| Manufacturer Phone | 9739891600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHANG PHACO CHOPPER |
| Generic Name | PHACO CHOPPER |
| Product Code | HNZ |
| Date Received | 2010-04-24 |
| Model Number | K3-2369 |
| Catalog Number | K3-2369 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS, INC. |
| Manufacturer Address | 4 STEWART COURT DENVILLE NJ 07834 US 07834 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-24 |