MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-21 for LEICA M320 M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.
| Report Number | 9213513 |
| MDR Report Key | 9213513 |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-01 |
| Date of Event | 2019-06-26 |
| Report Date | 2019-10-01 |
| Date Reported to FDA | 2019-10-01 |
| Date Reported to Mfgr | 2019-10-21 |
| Date Added to Maude | 2019-10-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 3 |
| Brand Name | LEICA M320 |
| Generic Name | MICROSCOPE, SURGICAL |
| Product Code | EPT |
| Date Received | 2019-10-21 |
| Model Number | M530 OH6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | 1700 LEIDER LANE BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-21 |