MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-22 for ARVEO manufactured by Leica Microsystems (schweiz) Ag.
| Report Number | 3003974370-2019-00013 |
| MDR Report Key | 9365643 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-07-31 |
| Date Facility Aware | 2019-10-24 |
| Report Date | 2019-10-24 |
| Date Reported to Mfgr | 2019-10-24 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2018-05-10 |
| Date Added to Maude | 2019-11-22 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROLAND JEHLE |
| Manufacturer Street | MAX-SCHMIDHEINY-STRASSE 201 |
| Manufacturer City | HEERBRUGG, SANKT GALLEN, 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 608924 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARVEO |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2019-11-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | MAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, SANKT GALLEN, 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-22 |