MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 70 DEG CURVED SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733450
Medical Device Problem Codes	Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A site representative reported that during functional endoscopic sinus surgery (fess), a 70 degree curved suction could not be recognized.A back up suction was used to complete the procedure.There was no delay to procedure.No impact on patient outcome.After procedure, a site representative was able to replicate the reported issue.
Additional Manufacturer Narrative
Correction: a medtronic representative reported that the instrument was unable to verify.
Additional Manufacturer Narrative
Further review found that the reported event was related to instrument verification during setup, and the reported issue was unlikely to cause serious harm.The initial mdr was submitted in error, and the reported event should not have been considered a reportable malfunction.
Additional Manufacturer Narrative
Device code was corrected.The curved suction was returned to manufacturer for evaluation.The testing found that the returned curved suction had difficulty verifying when attached to a known good tracker, returning a divot error of 1.8 mm to 2.1 mm.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 70 DEG CURVED SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7165460
• Report Number: 1723170-2018-00041
• Device Sequence Number: 13947848
• Product Code: HAW
• UDI-Device Identifier: 00613994378477
• UDI-Public: 00613994378477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2019

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 Catalogue Number: 9733450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/05/2018; 04/05/2018; 04/18/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/08/2018; 04/05/2018; 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1