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

Catalog Number 9735017

Device Problems Communication or Transmission Problem (2896); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Return requested for suspect malleable angle tip suction (b)(6) 2016.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a ear, nose & throat (ent) procedure, malleable suction verification issue.The instrument was functioning normally, however,unexpectedly stopped tracking.Another malleable suction was opened and was used to continue the procedure without issue.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

Usage or device and labeled for single use? values provided.The hardware investigation of the returned suction found that the reported event was related to an electrical issue.As reported, the suction was not identified and would not track when connected to a known good system.Coil #3 was nonfunctional and caused the issue.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6149838
• MDR Text Key: 61615973
• Report Number: 1723170-2016-05679
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169443525
• UDI-Public: 00643169443525
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Initial,Followup
• Report Date: 01/04/2017

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 Expiration Date: 12/30/2016
• Device Catalogue Number: 9735017
• Device Lot Number: 141231FR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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