MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-11 for STRAIGHT SUCTION, AXIEM 9733449 manufactured by Medtronic Navigation, Inc.
[183792379]
Udi not available for this system at time of filing. No parts have been received by the manufacturer for evaluation. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183792380]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported that intra-operatively, it was very difficult to register the straight suction. The surgeon had to manipulate the instrument for it to verify. The site continued the case with other instruments as the suction was not accurate after verification. The procedure was completed using the navigation system and there was no reported impact to patient outcome. There was no reported surgical delay due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00433 |
| MDR Report Key | 9693609 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2020-02-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRAIGHT SUCTION, AXIEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | PGW |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 9733449 |
| Catalog Number | 9733449 |
| Lot Number | 18081701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-11 |