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	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned for analysis.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).The surgeon was having difficulty verifying one of their straight suctions.It had a distance to divot value of 3.0 they swapped to another straight suction, and that verified immediately.There was a reported delay of less than one hour and no reported impact to patient outcome.After the case the surgeon tested the two suctions.The suction that did not verify was now verifying and the suction that was verifying was now returning a divot reading of >3.The report is on the first suction that was used.
Additional Manufacturer Narrative
Additional information: additional review of the returned part found that the suction failed the divot test and that the tip was not physically damaged or dented.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The suction was returned for analysis.Functional testing found that the suction was damaged and was unable to be verified.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information was received.It was noted by a representative that this issue was caused by the suction being bent.If information is provided in the future, a supplemental report will be issued.

• 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: 8219221
• Report Number: 1723170-2019-00096
• Device Sequence Number: 11170463
• Product Code: HAW
• UDI-Device Identifier: 00613994378422
• UDI-Public: 00613994378422
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/09/2019

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: 18042771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/07/2019; 03/07/2019; 03/25/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/29/2019; 03/25/2019; 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 62