MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CURVED SUCTION 90 9733451 EM ENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733451

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

The site declined to provide patient information, per (b)(4) privacy laws.Device manufacturing date is dependent on lot number, therefore, unavailable.A medtronic representative, following-up at the site, reported both suctions verified successfully without manipulation, and within a few seconds, however, were inaccurate by approximately 4 millimeters s/i and 2 millimeters a/p.All other instruments, including curved suctions from another tray, were accurate.The surgeon stopped using these instruments, and continued the procedure with minimal delay and no patient impact.On 11/15/2016, a medtronic representative performed a navigation system check-out, software and hardware areas passed.Instruments test failed.Curved suctions were several millimeters inaccurate.Items will need to be replaced.Recommended instrument replacement.Issue resolved.System performed as intended.It was reported that the suctions that were inaccurate were accidentally sent through the incorrect sterilization process by the site, because of this error, the suctions, became damaged.The site has been made aware and will replace the suctions.Return requested for curved suction 90 on 11/17/2016.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the surgeon alleged an inaccuracy occurred.The surgeon alleged a 4 millimeter inaccuracy with the curved 90 degree suction.All other instruments were accurate within 0.5 millimeters.Suction verified with no issue, however, the surgeon deemed being inaccurate using them.The doctor stopped using these instruments and continued the procedure.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

Correction to event date now provided.Correction to aware date now provided on initial mdr submitted: (b)(6) 2016.Additional information: although a specific cause of the reported incident was unconfirmed as the part was not received to the manufacturer, an investigation into returned parts with similar reported malfunctions was completed via capa investigations.

• Brand Name: CURVED SUCTION 90 9733451 EM ENT
• Type of Device: NEUROLOGICAL 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: oksana ditolla ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6175811
• MDR Text Key: 62544069
• Report Number: 1723170-2016-05771
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994378460
• UDI-Public: 00613994378460
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: 9733451
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1