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 2016-09-29 for OPMI PICO ON S100 FLOOR STAND 000000-1245-414 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[55934105]
A field service engineer (fse) performed an on-site inspection and found that the two screws of the mounting plate securing the xenon power supply illumination unit to the s100 floor stand were broken. The fse repaired the holding mecahnism and put the microscope back into service.
Patient Sequence No: 1, Text Type: N, H10
[55934106]
The health care professional reported the following: when switching off the opmi pico microscope on an s100 floor stand after finishing the oral procedure, the nurse noticed that the lamp housing was loose and only hanging on one screw. Then, the lamp housing came completely loose and the nurse was able to catch the lamp housing. The part did not fall on the floor nor hit anyone. The procedure had already been completed and no patient was involved. No one was injured due to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00014 |
| MDR Report Key | 5987231 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-29 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2016-09-02 |
| Device Manufacturer Date | 2013-12-16 |
| Date Added to Maude | 2016-09-29 |
| 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. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PICO ON S100 FLOOR STAND |
| Generic Name | OPMI PICO MICROSCOPE |
| Product Code | FSO |
| Date Received | 2016-09-29 |
| Model Number | NA |
| Catalog Number | 000000-1245-414 |
| Lot Number | NA |
| 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 | 2016-09-29 |