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

Model Number 9735015

Device Problem Material Integrity Problem (2978)

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

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information requested.The suction was returned to the manufacturer for analysis.Analysis found that the instrument would not track.Analysis found that the reported event was related to a electrical issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the malleable suction stopped tracking after no difficulty for 20 minutes.Instrument replacement resolved the reported issue.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

Patient information was unavailable from the site.Additional information: patient information was requested, but site indicated that this information is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the malleable suction stopped tracking after no difficulty for 20 minutes.Instrument replacement resolved the reported issue.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.

• Brand Name: MALLEABLE SUCTION SMALL, STANDARD 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: 8125339
• MDR Text Key: 129067891
• Report Number: 1723170-2018-06011
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

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 Expiration Date: 10/27/2019
• Device Model Number: 9735015
• Device Catalogue Number: 9735015
• Device Lot Number: 171027G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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