MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STRAIGHT SUCTION 9733449 EM ENT; INSTRUMENT, STEREOTAXIC

Model Number	9733449
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was refused to be provided by the site.The straight suction was returned to the manufacturer for analysis.Analysis found that the returned straight suction was not able to verify when attached to a known good tracker returning a divot error of 2.3mm to 2.7mm.The tip of the suction also had several nicks.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred preoperatively and caused no delay to the surgery.It was reported that the tip of the straight suction was deformed before the procedure started.The straight suction would have passed verification despite the damage.The instrument was not used and replaced with another straight suction.The surgery was completed with navigation and there was no impact on patient outcome.

• Brand Name: STRAIGHT SUCTION 9733449 EM ENT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8410425
• Report Number: 1723170-2019-01056
• Device Sequence Number: 16221370
• Product Code: HAW
• UDI-Device Identifier: 00763000053369
• UDI-Public: 00763000053369
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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: Health Professional
• Device Model Number: 9733449
• Device Catalogue Number: 9733449
• Device Lot Number: 21830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1