MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for FUSION COMPACT NAVIGATION SYSTEM manufactured by Medtronic Navigation, Inc..
[88060870]
Patient Sequence No: 1, Text Type: N, H10
[88060931]
A female was scheduled to undergo a functional endoscopic sinus surgery (fess) procedure. She was brought to the or and induced with general anesthesia. She was prepped and draped and the navigation system was brought onto the field, and during the procedural timeout, it was noted that the ct image guidance system was not functioning properly. All staff in the room were very familiar with the procedure and the equipment. The surgeon was able to register the patient and was able to verify straight suction. However, when she attempted to use it, she could not get the tracing to work and the crosshair changed to red - indicating a poor signal. Trouble-shooting was attempted to restore functionality with phone assistance by medtronic rep - including re-booting, moving patient tracker, changing instrument tracker and re-registering, but this did not resolve the problem. The staff did not agree to move the emitter - but staff in the room familiar with the equipment confirmed that the setting was good. After approximately an hour during which the patient was under anesthesia, the surgeon decided to abort the case. The surgeon met with the patient and explained what happened and the patient was re-booked for a few weeks later. The surgeon reported this event to the company. The or reported the event to risk management when the company contacted her. The equipment reportedly also posed problems for 1-3 other surgeons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6910169 |
| MDR Report Key | 6910169 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-06 |
| Report Date | 2017-09-28 |
| Date Reported to FDA | 2017-09-28 |
| Date Reported to Mfgr | 2017-09-28 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSION COMPACT NAVIGATION SYSTEM |
| Generic Name | EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT |
| Product Code | OGR |
| Date Received | 2017-10-03 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC. |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-03 |