MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-04 for VISU 200 ON S8 FLOOR STAND N/A manufactured by Carl Zeiss Meditec Ag (oberkochen).
[141027971]
A health care professional (hcp) reported that when the surgeon finished surgery and moved the opmi visu 200 microscope away, the microscope's stand swivel arm broke and the microscope moved downside. There was no injury reported to the patient or the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2019-00002 |
| MDR Report Key | 8485112 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-04 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2001-10-11 |
| Date Added to Maude | 2019-04-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VERNON BROWN |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISU 200 ON S8 FLOOR STAND |
| Generic Name | MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2019-04-04 |
| Model Number | VISU 200 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |