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 2018-07-05 for BALLOON SEEKER FRNT 7X17MM 1830717FRT manufactured by Medtronic Ent (jacksonville).
[113287973]
Unique device identification not available. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated. The system then passed the system checkout and was found to be fully functional. The frontal balloon seeker was returned to the manufacturer for analysis. Analysis found that when connected to a known good system, the balloon seeker was not recognized and would not track. Unable to perform accuracy test. Analysis found that the reported event was related to a electrical issue.
Patient Sequence No: 1, Text Type: N, H10
[113287974]
Medtronic received information regarding a navigation system. It was reported that intra/peri-operatively during the navigate task of a functional endoscopic sinus surgery (fess) procedure, the surgeon experienced an alleged inaccuracy of 2-2. 5mm posterior while using a frontal balloon. No inaccuracy observed with any other instrument, the site chose not to use the balloon. There was delay to the procedure of less than one hour and there was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[117732045]
Additional information: software analysis and archive analysis. A software investigation analysis was initiated to determine the probable cause of the issue through log analysis. Review of the logs found no information to conclude software caused the issue. Archive examination found that registration points were collected beneath the skin with no green zones of accuracy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723170-2018-03144 |
| MDR Report Key | 7664063 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-05 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-07-28 |
| Date Added to Maude | 2018-07-05 |
| 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 | JACK EDELL |
| Manufacturer Street | NAVIGATION CUSTOMER QUALITY 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 800279710 |
| Manufacturer Country | US |
| Manufacturer Postal | 800279710 |
| Manufacturer Phone | 7208902515 |
| Manufacturer G1 | MEDTRONIC ENT (JACKSONVILLE) |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON SEEKER FRNT 7X17MM |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-07-05 |
| Returned To Mfg | 2018-06-18 |
| Catalog Number | 1830717FRT |
| Lot Number | M726750C745A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ENT (JACKSONVILLE) |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |