MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-19 for KATENA DRYSDALE NUCLEUS MANIPULATOR manufactured by Katena Products, Inc..
[20712083]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20865404]
Eval results: subject instrument fabricated (b)(6) 2007. Magnified visual exam of the returned instrument found no objective evidence suggestive of a mfg or material defect. Surface scratches visible on the device polished tip and shaft may suggest instrument making contact with the phacoemulsification probe during use. High power magnification, also found discoloration in the end of the shaft where break occurred. Discoloration could indicate a micro fracture that may have been the result of inadvertent contact with phacoemulsification probe. Overall, no final conclusion could be drawn from visual exam of returned. User facility requested the instrument be returned to them. Suspect this was an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242450-2008-00001 |
| MDR Report Key | 3167771 |
| Report Source | 05 |
| Date Received | 2008-06-19 |
| Date of Report | 2008-05-16 |
| Date of Event | 2008-05-09 |
| Date Facility Aware | 2008-05-09 |
| Report Date | 2008-05-16 |
| Date Reported to Mfgr | 2008-05-28 |
| Date Mfgr Received | 2008-06-02 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2013-06-14 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 4 STEWART CT. |
| 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 | KATENA DRYSDALE NUCLEUS MANIPULATOR |
| Generic Name | DRYSDALE NUCLEUS MANIPULATOR |
| Product Code | HND |
| Date Received | 2008-06-19 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS, INC. |
| Manufacturer Address | DENVILLE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-19 |