MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERDIMENSION INREACH SYSTEM; ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY

Model Number AAS00161-20U

Device Problem Circuit Failure (1089)

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

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

A site service visit was completed and a component of the superdimension system was returned and evaluation which resulted in an open circuit due to a blown fuse.Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.

Event Description

Site reported they were not seeing the targets displayed by the patient sensor triplet (pst) during an enb procedure and the physician cancelled the case.The patient was under general anesthesia.There was no report of patient injury, death or other serious adverse event.

• Brand Name: SUPERDIMENSION INREACH SYSTEM
• Type of Device: ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 6206158
• MDR Text Key: 63328341
• Report Number: 3004962788-2016-00299
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AAS00161-20U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1