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

Catalog Number 9735018

Device Problems Device Stops Intermittently (1599); Suction Problem (2170); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

A medtronic representative received a report from a site that a ball tip malleable suction stopped tracking approximately 1 hour after being used in a functional endoscopic sinus surgery (fess).Instrument was still suctioning but not tracking.In trouble-shooting, re-plugging the cable into the axiem box did not resolve the issue.It was confirmed there was no metal in the field.Delay in surgery was 6 minutes.The surgeon opted to use the ball tip malleable suction to continue and completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Return requested.Returned suspect ball tip malleable suction is under analysis.

Manufacturer Narrative

Correction: instrument was a single use disposable device.Further engineering analysis found two potential causes to the reported event related to operator technique.There was a cut in the area of the coils and connections that was consistent with contact by another instrument, such as a m4 blade.There was also a slight bend in the no-bend area at the tip.Both of these situations would have stopped navigation during use.The device was replaced to resolve the issue.

Manufacturer Narrative

The device was returned to the manufacturer for analysis.The suction instrument showed red status and would not navigate.One of the three coils was open.The reported event was confirmed to be caused by an electrical issue.The device was replaced to resolve the issue.

• Brand Name: MALLEABLE SUCTION MEDIUM, BALL TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4301537
• MDR Text Key: 5054434
• Report Number: 1723170-2014-01328
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2014

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: Physician
• Device Catalogue Number: 9735018
• Device Lot Number: 140611G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/11/2014; 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 67