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..
[88060853]
Patient Sequence No: 1, Text Type: N, H10
[88060854]
A female patient was scheduled to undergo a bilateral functional endoscopic sinus surgery (fess) procedure. She was brought to the or and induced with general anesthesia. The navigation system was brought onto the field and it initially malfunctioned. The surgeon was able to successful register the patient's anatomy to the pre-operative ct scan, but was unable to register the instruments (suctions) to the system. The team was able to trouble shoot the problem with help from the company via phone and were able to get the equipment to properly register. The company rep suggested that the staff post trouble-shooting instructions (4 specific actions) in the room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6910565 |
| MDR Report Key | 6910565 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-07 |
| 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 | N |
| 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 | 2017-10-03 |