MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-08 for STORZ E 0590 manufactured by Storz.
[17732750]
During cataract surgery for pt, the seibel chopper instrument tip was missing after use on the pt's right eye. No tip at operative site. Visual with microscope done by physician and x-ray. The x-ray was negative. Instrument is microscopic with a microscopic tip. Dose, frequency & route used: na. Diagnosis for use: na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011854 |
| MDR Report Key | 1413529 |
| Date Received | 2009-07-08 |
| Date of Report | 2009-07-08 |
| Date of Event | 2009-04-22 |
| Date Added to Maude | 2009-07-21 |
| 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 | STORZ |
| Generic Name | CHOPPER AMBIDEXTROUS |
| Product Code | HND |
| Date Received | 2009-07-08 |
| Model Number | E 0590 |
| Catalog Number | E 0590 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-08 |