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

Catalog Number 9735016

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Return requested.(b)(6) 2015 reported the suspect malleable suction was discarded by the site and will not be returned to manufacturer for analysis.On (b)(6) 2015 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(6) 2015 a medtronic representative, following-up at the site, reported performing a system check-out which indicated that the navigation system was working as intended.Since this time, the site has performed one subsequent procedure with the standard ear, nose & throat (ent) instrument tray with no issues.Issue resolved.- no parts have been received by manufacturer for analysis.- no further issues have been reported.

Event Description

A medtronic representative reported that, while in an ear, nose & throat (ent) procedure, the physician felt inaccurate by 2-3 millimeters toward the right.The inaccuracy was noted when using the malleable suction.In trouble-shooting, the surgeon re-registered the patient and the same issue happened twice.The surgeon opted to continue without using the malleable suction and had no further accuracy issues.There was no delay of therapy reported.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Device mfg date now provided.

Manufacturer Narrative

The manufacture date provided on follow up #1 was actually for the fusion navigation system, which was used with the malleable suction, and is now listed as a concomitant product on this follow up.The manufacture date for the malleable suction could not be determined as the lot # was not provided by the site prior to disposing of the instrument.

Manufacturer Narrative

Device manufacture date provided.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5157396
• MDR Text Key: 28564018
• Report Number: 1723170-2015-01250
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K133665
• 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: Followup,Followup,Followup
• Report Date: 07/30/2008,01/12/2016

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
• Date Report to Manufacturer: 07/30/2008
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/13/2015; 12/09/2015; 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2015
• 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
• Patient Age: 54 YR
• Patient Weight: 83