MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-12 for OPMI PICO ON S100 FLOORSTAND N/A 000000-1095-102 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[141912610]
A zeiss field service engineer (fse) performed an on-site inspection of the microscope. The fse determined that the binoculars fell off as a result of a loose set screw, which had not been sufficiently tightened by the user, and not as a result of a device malfunction. It was concluded that the user did not check and firmly tighten the set screw before using the microscope. The user manual gives clear instruction to make sure that all accessories are securely mounted. The user has been reinformed about the importance of performing safety and function checks before every use of the microscope.
Patient Sequence No: 1, Text Type: N, H10
[141912611]
The binocular of the opmi pico microscope mounted on a s100 floor stand detached and fell on a doctor. It was reported that the doctor sustained a bruise on her shoulder. No additional information could be obtained from the site regarding the extent of the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2019-00003 |
| MDR Report Key | 8511738 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2011-04-11 |
| Date Added to Maude | 2019-04-12 |
| 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 | DENTIST |
| 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 | OPMI PICO ON S100 FLOORSTAND |
| Generic Name | OPMI PICO |
| Product Code | FSO |
| Date Received | 2019-04-12 |
| Model Number | N/A |
| Catalog Number | 000000-1095-102 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2019-04-12 |