MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MALLEABLE SUCTION MEDIUM, STANDARD TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 9735016

Device Problems Bent (1059); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device lot number, or serial number, unavailable as part was discarded.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Rma issued; replacement device shipped to site for issue resolution.Part was discarded on site in the hospitals biohazard container.

Event Description

A medtronic representative reported that during a functional endoscopic sinus surgery (fess) the navigated suction instrument stopped tracking mid-way into the case while in the patient's nose.The medtronic representative provided a replacement suction and the surgeon completed the procedure with the use of the navigation system.The reported delay was less than 5 minutes.There was no impact on patient outcome.

• Brand Name: MALLEABLE SUCTION MEDIUM, STANDARD TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 5329526
• MDR Text Key: 34473964
• Report Number: 1723170-2015-01642
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1