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

Catalog Number	9735017
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6149838
• Report Number: 1723170-2016-05679
• Device Sequence Number: 10856698
• Product Code: PGW
• UDI-Device Identifier: 00643169443525
• UDI-Public: 00643169443525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1