MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MALLEABLE SUCTION LARGE, STANDARD TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 9735019

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the malleable suction was unable to navigate during the procedure.The site elected to use a separate malleable suction to complete the procedure.No additional information was provided.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

• Brand Name: MALLEABLE SUCTION LARGE, STANDARD TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6560627
• MDR Text Key: 74948208
• Report Number: 1723170-2017-02045
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169443549
• UDI-Public: 00643169443549
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/21/2018
• Device Catalogue Number: 9735019
• Device Lot Number: 160621C
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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: 34 YR
• Patient Weight: 113