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

Model Number AAS00161-20

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.There were no anomalies identified during the internal review of the dhr of the system console.Once the patient left the procedure room it was found that the location board had been placed backwards on the bed.Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If additional information is received a follow-up report will be submitted.

Event Description

The site reported difficulty with registration during a suerdimension procedure.When the sensor catheter was turned one way it appeared to go in the opposite direction on the system monitor.The case was cancelled and the patient was under general anesthesia.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: SUPERDIMENSION INREACH BRONCHUS 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: 5051846
• MDR Text Key: 25508550
• Report Number: 3004962788-2015-00066
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/02/2015

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 Model Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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