MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-19 for KATINA K3-2418 manufactured by Katina.
[20230063]
Tip of drysdale nucleus manipulator broke during procedure. The broken instrument was discovered after the case was complete. X-rays were taken. Tip of instrument surfaced 5 days later at which time it was removed from the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3167813 |
| MDR Report Key | 3167813 |
| Date Received | 2008-06-19 |
| Date of Report | 2008-05-16 |
| Date of Event | 2008-05-09 |
| Date Facility Aware | 2008-05-09 |
| Date Reported to Mfgr | 2008-05-28 |
| Date Added to Maude | 2013-06-14 |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KATINA |
| Generic Name | DRYSDALE NUCLEUS MANIPULATOR |
| Product Code | HND |
| Date Received | 2008-06-19 |
| Model Number | K3-2418 |
| Catalog Number | K3-2418 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATINA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-19 |