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 2020-02-26 for STRAIGHT SUCTION 9733449 manufactured by Medtronic Navigation, Inc.
[184089718]
Udi not available for this instrument. 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
[184089719]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported that intra-operatively, the surgeon had difficulty verifying their straight suction. The surgeon needed to rotate the instrument after about ten attempts and finally could get it to verify. The procedure was completed using the navigation system and there was no reported impact to patient outcome. There was a reported delay to the procedure of less than one hour due to this issue. Medtronic received additional information that the cause or contributing factors related to the reported issue was that the instrument must have been slightly bent causing it to not verify easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00651 |
| MDR Report Key | 9757415 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | STRAIGHT SUCTION |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | PGW |
| Date Received | 2020-02-26 |
| Model Number | 9733449 |
| Catalog Number | 9733449 |
| Lot Number | 27167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-26 |