MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for CURVED SUCTION 70 9733450 manufactured by Medtronic Navigation, Inc.
[185085493]
The suction was returned and analyzed. The suction was not able to verify when attached to a known good tracker returning a divot error of 2. 4 mm to 2. 7 mm. Codes 10, 180 and 4307 are applicable to this analysis. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185085494]
No issue was alleged. Medtronic received information received information regarding a navigation system that was discovered during initial testing of instruments when un-crating the system for a trial. It was reported that the 70 degree suction would not verify. Distance to divot was given as 3. 7-4. 2mm. They were able to verify if the instrument hovered above the divot. It was also reported that the instrument was damaged. There was no patient present at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01078 |
| MDR Report Key | 9884278 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| 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 | CURVED SUCTION 70 |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-20 |
| Model Number | 9733450 |
| Catalog Number | 9733450 |
| Lot Number | 11515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-26 |