MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for CALLISTO manufactured by Carl Zeiss Meditec Ag.
[46387760]
Patient Sequence No: 1, Text Type: N, H10
[46387761]
The calisto machine was placed in one of the operating rooms. The surgeon was not able to get an image. The staff attempted to solve the issues with many attempts but were unsuccessful. The other calisto was placed in the room, but then all the information from the usb port was lost when it was placed in the first calisto machine. The staff went back to the clinic to install all the patient information into the usb port and then come back to operating room, causing a 30 minute delay. The surgeon notified the patient of the issue. The surgery then continued as normal. It was later determined that the software was not installed; the vendor installed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5694212 |
| MDR Report Key | 5694212 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-25 |
| Report Date | 2016-05-31 |
| Date Reported to FDA | 2016-05-31 |
| Date Reported to Mfgr | 2016-05-31 |
| Date Added to Maude | 2016-06-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALLISTO |
| Generic Name | TOMOGRAPHY, OPTICAL COHERENCE |
| Product Code | OBO |
| Date Received | 2016-06-02 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | 5160 HACIENDA DR. DUBLIN CA 95030 US 95030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |