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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH PLATFORM; BRONCHOSCOPE (FLEXIBLE OR RIGID)
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AURIS HEALTH, INC. MONARCH PLATFORM; BRONCHOSCOPE (FLEXIBLE OR RIGID) Back to Search Results
Model Number MBR-000012
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2019
Event Type  malfunction  
Event Description
The aspirating biopsy needle was used with the monarch bronchoscope system to successfully obtain 4 samples without incident.Switching to an olympus scope and moving to a new target site with more fibrous tissue to acquire a 5th sample, the distal portion of the needle was fractured.There were no patient complications reported as a result of this event.This is under investigation and a supplemental report will be provided.
 
Manufacturer Narrative
Through investigation, it was determined that the needle breakage was likely a result of off-label use by the clinician.As per the instructions for use, device compatibility is restricted to use of the biopsy needle with the monarch¿ endoscopy platform.
 
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Brand Name
MONARCH PLATFORM
Type of Device
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Manufacturer (Section D)
AURIS HEALTH, INC.
150 shoreline drive
redwood city CA 94065
MDR Report Key8423382
MDR Text Key142626370
Report Number3014447948-2019-00002
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
PMA/PMN Number
K173760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/29/2019
Device Model NumberMBR-000012
Device Lot NumberRS181129-2
Was Device Available for Evaluation? Yes
Event Location Hospital
Date Manufacturer Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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