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 2017-08-25 for OPMI PICO ON S100 FLOORSTAND 000000-1095-094 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[83724627]
A zeiss field service engineer (fse) performed an on-site inspection of the microscope. The fse determined that the binocular tube fell as a result of a loose securing 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 securing screw before using the microscope. The user manual (g-30-1781-en, version 6. 0, pages 14, 97, 102, 137) 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 befrore every use of the microscope.
Patient Sequence No: 1, Text Type: N, H10
[83724628]
The health care professional (hcp) reported that during a surgical procedure, the binocular tube with eyepieces was loose and fell off the microscope. The binocular tube made contact with the hcp before falling to the floor and breaking. The hcp suffered a laceration on the head, which required medical treatment. The hcp was able to finish the procedure successfully with no negative impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00008 |
| MDR Report Key | 6822961 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 2014-03-26 |
| Date Added to Maude | 2017-08-25 |
| 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 | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PICO ON S100 FLOORSTAND |
| Generic Name | OPMI PICO |
| Product Code | FSO |
| Date Received | 2017-08-25 |
| Model Number | NA |
| Catalog Number | 000000-1095-094 |
| 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. Required No Informationntervention | 2017-08-25 |