MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH PLATFORM, UROLOGY; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number MUR-000011

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Event Description

During the clinical study trial case unexpected video quality was observed on ureteroscope.The unexpected video quality consisted of blurriness on the system display.The blurry vision was only observed during mini-percutaneous nephrolithotomy (pcnl) procedure of the product workflow, namely during ureteroscope driving with the laser driver component connected.Upon replacement of the ureteroscope, no further video issues were observed and the user completed the case.Under preliminary investigation the ureteroscope was examined under magnification, at which time it was discovered that the top layer of the camera lens was missing.There were no reported adverse effects to the patient because of the system issues.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by auris health, inc., or its employees that the report constitutes an admission that the product, auris health, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

In investigation of returned product, it was discovered that at least one layer of the camera lens stack had delaminated, leaving a vacant rectangular hole in the ureteroscope tip.Review of case video identified there was a user error which violated our ifus.The user was actuating the laser fiber and commanded laser fiber retracting.The laser fiber was not visible in the camera image as it was fired.Our ifus state that the laser fiber must only be actuated when the fiber takes up ~1/3 of the camera field of view (fov).The image blurriness began immediately after this event.It was identified that this delamination occurred due to this erroneous use of the laser.

• Brand Name: MONARCH PLATFORM, UROLOGY
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline drive; redwood city, CA 94065 ; 6282544750
• MDR Report Key: 18813288
• MDR Text Key: 336615902
• Report Number: 3014447948-2024-00002
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MUR-000011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/16/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other