MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-09 for PENTERO 900 manufactured by Zeiss.
[134315574]
During "the performing" a right craniotomy for evacuation of a hematoma and clipping of a ruptured aneurysm, after applying the temporary clips the zeiss microscope froze and flashed a green error through the oculars. Scope was using the primary position. Staff shut off the scope and rebooted it. Failed again. This caused a delay about 15 mins during which "due to" the temporary clips on the carotid and anterior cerebral artery resulted in a significant stroke. It is unclear if this was a survivable situation for the pt from the beginning, but the failure of the microscope caused significant harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8281817 |
| MDR Report Key | 8281817 |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-10-18 |
| Date Facility Aware | 2018-10-22 |
| Report Date | 2019-01-07 |
| Date Reported to Mfgr | 2018-10-22 |
| Date Added to Maude | 2019-01-28 |
| 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 | 0 |
| Brand Name | PENTERO 900 |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | FSO |
| Date Received | 2019-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZEISS |
| Manufacturer Address | DUBLIN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-01-09 |