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

Catalog Number 9735017

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that during a functional endoscopic sinus surgery (fess) a navigated suction instrument stopped tracking.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.No further information was provided.

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(4).Suspect suction instrument was discarded by the site.Discarded by site.

Manufacturer Narrative

On 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2016.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2016.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.

Manufacturer Narrative

Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.

• Brand Name: MALLEABLE SUCTION MEDIUM, ANGLE 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: 4821529
• MDR Text Key: 20145825
• Report Number: 1723170-2015-00670
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/05/2015,02/19/2016

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: 9735017
• Device Lot Number: 141010F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/05/2015
• Distributor Facility Aware Date: 05/07/2015
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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: 44 YR
• Patient Weight: 77