MAUDE Adverse Event Report: AURIS HEALTH, INC. ASPIRATING BIOPSY NEEDLE; BRONCHOSCOPE (FLEXIBLE OR RIGID),

Catalog Number MBR-000012

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/26/2019

Event Type  malfunction  

Event Description

The aspirating biopsy needle was used for biopsy with the monarch endoscopy platform (monarch platform).During the case, the distal portion of the needle was fractured.The physician was able to retract the scope to retrieve the needle tip by catching it with the scope.The staff confirmed that no material was left inside the patient, and there were no patient complications reported as a result of this event.

Manufacturer Narrative

Device evaluation summary: an evaluation was performed on the subject device.Trend analysis and testing of devices from other lots were performed.The investigator was able to reproduce the needle failure and concluded that the needle kinked due to passing or articulating the needle through a damaged scope lumen.When passed through the damaged lumen after becoming kinked, the needle broke off at the site of the kink.The use of the biopsy needle through a damaged scope lumen most likely caused the needle to kink and break.

• Brand Name: ASPIRATING BIOPSY NEEDLE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID),
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer Contact: elizabeth osuna ; 150 shoreline drive; redwood city, CA 94065 ; 6504436730
• MDR Report Key: 8547835
• MDR Text Key: 147622202
• Report Number: 3014447948-2019-00004
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2019
• Device Catalogue Number: MBR-000012
• Device Lot Number: 181210-3
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3014447948-04/25/19-001C
• Patient Sequence Number: 1