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

Model Number 9735017

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

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

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

The second suction was returned to medtronic for analysis.Analysis revealed that the second suction could be recognized when connected to a known good system but would not track.A check of the electromagnetic interface showed all three coils dead for the second suction.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that when using the suction, it stopped tracking/responding midway through, so a back-up suction was used.This back-up suction also stopped tracking/responding midway through.The procedure was completed by using another back-up suction.There was no delay to the procedure and no impact to patient outcome as a result of this issue.Note: this report is to document the second of the two instruments that stopped tracking/responding midway through use.

• Brand Name: SUCTION MALLEABLE ANGLE TIP
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9126132
• MDR Text Key: 160306132
• Report Number: 1723170-2019-05029
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2019

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
• Device Operator: Health Professional
• Device Model Number: 9735017
• Device Catalogue Number: 9735017
• Device Lot Number: 190327B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1