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

Model Number AAS00161-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 09/15/2015

Event Type  Injury  

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.Out of an abundance of caution, superdimension is filing this mdr due to the unexpected level of pain reported though no intervention was required.If additional information is received a follow-up report will be submitted.

Event Description

The patient reported experiencing an unexpected level of pain one week following a superdimension procedure however the pain resolved spontaneously without intervention.

Manufacturer Narrative

This event did not require medical intervention and does not meet the criteria for a serious injury therefore is not a reportable event.

• 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: 5204582
• MDR Text Key: 30509400
• Report Number: 3004962788-2015-00111
• Device Sequence Number: 1
• Product Code: EOQ
• 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
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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
• Patient Outcome(s): Other