MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH PLATFORM; BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model Number MON-000006

Device Problems Mechanical Problem (1384); Device Damaged Prior to Use (2284); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2022

Event Type  malfunction  

Event Description

During a monarch bronchoscopy procedure it was reported the customer had two bronchoscopes in a row that produced fault id: (b)(4) , poor quality scope em data detected during navigation (nav) registration.The first instance occurred during nav registration immediately after pressing set roll correction.The customer proactively power-cycled the system and switched to a second bronchoscope; however, the error persisted.The customer couldn¿t perform the monarch procedure and the case was aborted.There was no reported harm to the patient.

Manufacturer Narrative

Failure analysis engineering received multiple impacted products under the complaint, as follows: 1.) two scopes (mbr-000211-a): investigations were covered under (b)(4) and (b)(4), both concluded that the scopes met specifications as reported issue was not replicated and no inconsistent behavior observed.2.) one umbilical cable pn (300-0024218-00), investigation covered under (b)(4).Upon visual inspection, shows damaged/broken and bent pins inside the lemo connector.Functionally, the cable was installed on a known-good-system to try to replicate the reported issue.System boot up sequence and system initialization operated normally and as intended.Upon running a test case using a lung model, navigation registration was completed successfully with no faults of any kinds.A drive test was performed for 20 minutes, and during that period, no faults or any inconsistent functional system behavior observed.During bench test, a continuity test was performed between the subject umbilical cable and the returned mating bulkhead assembly.Continuity test failed on both pins 7 and 8 (same pins found recessed by visual inspection).The assembly wiring diagram for this cable assembly was reviewed, it was confirmed that pins 7 and 8 are part of the ethernet communication line ¿x2¿ which connects to the tower communication switch.Although the disconnection was confirmed on the cable, it most likely would not cause the 1200 faults, however, there would be a possibility that a communication/initialization fault might be triggered.Reviewing the logs in s3 (studydata/2022-12-29/system(b)6)_man/{6616b7b3-ec43-4d07-9fe9-22dbd6c18d77}/upload/protologs/), it was confirmed that the system experienced an ethercat initialization fault 1405-50-0-0.The logs showed that only one slave (address 1001) was detected during the system bootup sequence for the day, after system reboot, system initialized properly.Upon dis-assembly, it was also noticed that there are some scuff marks present of the lemo connector nut.This was discussed with the cable¿s supplier and confirmed it is caused by the lemo flat spanner being worn-out or have play nature when used.In-addition, the pin tip found bent which suggest it was deflected before it got recessed.The pins getting recessed on the umbilical cable is a known issue, that is due to the design of the component.When the pins are deflected and not straight, it would hit the mating part insulation which applies high retention forces the umbilical cable pins are unable to withstand, leading to pins being recessed.Bulkhead assembly, cable, cart, umbilical to computer and pdu, solder (300-021048-00).Upon visual inspection, shows damages to the insulation due to the bent/broken pins inside the mating part lemo connector (umbilical cable) investigated under (b)(4).Functionally, the bulkhead assembly was fully functional despite the damages to the insulation.A mating test was performed using good-known- umbilical cable to re-produce the failure.The bulkhead was subjected to x40 of mating/de-mating cycles.No damage further damage was created on the bulkhead, nor any damages observed of the test umbilical cable.This confirms that the issue caused by the original umbilical cable that was returned and investigated on (b)(4).Conclusion: the reported issue was confirmed through the logs, however, was never replicated during the investigation on all returned products.Scopes functioned as designed with no inconsistent behavior observed.The failure on the umbilical cable and bulkhead assembly is a known issue, that is due to the assembly process of the component (lemo connector), when the pins are deflected and not straight, it would hit the mating part insulation which applies high retention forces the umbilical cable pins are unable to withstand, leading to pins being recessed.A review of the system history record (dhr) showed no non-conformances reported that is related to the reported event.This issue will be tracked and trended in the monthly complaint trend review meetings.

• Brand Name: MONARCH PLATFORM
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• 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: harminder kaur ; 150 shoreline drive; redwood city, CA 94065 ; 5106057113
• MDR Report Key: 16236540
• MDR Text Key: 308746645
• Report Number: 3014447948-2023-00003
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20210420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MON-000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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