MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STRAIGHT SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733449

Device Problems Bent (1059); Device Issue (2379); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date now provided.

Event Description

A medtronic technical services representative reported that, while in a transsphenoidal procedure, the site's straight suction instrument was damaged.This occurred after initially verifying the instrument and navigating for two hours without issue.At this point, the surgeon was navigating in the sphenoid when alleging that the straight suction was inaccurate by 1 centimeter.In trouble-shooting, the patient was re-registered using tracer, however, the straight suction instrument could not be verified.The medtronic representative noted that the site was grabbing the instrument from the suction tubing instead of from the handle.The site was instructed to change the suction on the instrument by grabbing the handle, not the shaft and tubing, to avoid bending of the instrument.A medtronic ear, nose & throat (ent) representative brought a different straight suction in to be used for the remainder of the procedure.The surgeon continued and completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Return requested.Replacement straight suction shipped to site 02/17/2015.No parts have been received by manufacturer for analysis.Part not returned to manufacturer.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: STRAIGHT SUCTION, AXIEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4610536
• MDR Text Key: 13190437
• Report Number: 1723170-2015-00330
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733449
• Device Lot Number: 25477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2014
• 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
• Patient Weight: 82