MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SYSTEM 9733560XOMR FUSION; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9733560XOMR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9731203, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the surgeon had difficulty verifying instruments and registering the patient.It is unknown what the geometry error on the patient tracker was, as they called him to report after the conclusion of the procedure.The site was able to verify and register to complete the procedure.The manufacturer representative was on site to check the system and was able to verify the straight suction with a distance-to-divot value of 1.9mm, without issue, although the tracking field appeared to be closer to the emitter than normal while he had the emitter mounted on the fusion rail.He stated that there isa visible crack on the emitter.There was a reported delay of there was a 30-40 minutes.There is no known impact on patient outcome.It was reported that instrument manipulation was done.The instrument was placed in various positions to achieve verification.

Manufacturer Narrative

H2: additional information: d11 updated with serial number.D11) serial #: (b)(6).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYSTEM 9733560XOMR FUSION
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10247168
• MDR Text Key: 198410779
• Report Number: 1723170-2020-01863
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (y/n): N
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: 4501314417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR