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 2018-11-07 for OPMI VARIO N/A 000000-1026-700 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[126505788]
According to the manufacturer the failure of the focus function occurred due to an incorrect fitting of a third party drape to the device. The drape got tangled around the focus knob causing it to become stuck. The user manual instructs the user to ensure the proper draping of the system to allow proper movement of the microscope. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126505789]
A health care professional (hcp) reported that the focus function of the opmi vario microscope stopped working after 1 hour and 30 minutes into a surgery. The system displayed error #12, related to the zoom end position. The hcp decided to abort the procedure and rescheduled it for a later date. No adverse consequences to the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00014 |
| MDR Report Key | 8049027 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-07 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-10-08 |
| Device Manufacturer Date | 2016-11-07 |
| Date Added to Maude | 2018-11-07 |
| 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. VERNON BROWN |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI VARIO |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2018-11-07 |
| Model Number | N/A |
| Catalog Number | 000000-1026-700 |
| 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 | 2018-11-07 |