MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-16 for ZEISS manufactured by Carl Zeiss Meditec.
[65456624]
Physician was adjusting the microscope to start the cataract surgery and the primary optic source fell off catching the rt side of the drape and the patient's forehead. Bruising was noted on patient's forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067312 |
| MDR Report Key | 6263079 |
| Date Received | 2017-01-16 |
| Date of Report | 2017-01-16 |
| Date of Event | 2017-01-16 |
| Date Added to Maude | 2017-01-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZEISS |
| Generic Name | ZEISS MICROSCOPE FOR OPHTHALMOLOGY PROCEDURES |
| Product Code | EPT |
| Date Received | 2017-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-16 |