MAUDE Adverse Event Report: BODY VISION MEDICAL, LTD. LUNG VISION SYSTEM; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	LV105502
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After successfully completing the first procedure of the day, dr.(b)(6) was waiting for the procedure application to finish processing the case data and close.While waiting for this process to complete the clinician performed the hard shutdown of the tablet and then restarted it without restarting the whole system, including tablet and main unit, as recommended by vendor.This caused the tablet and main unit to become out of sync in the subsequent two cases that day.During cases 2 and 3, false cabt error messages were displayed during main carina registration.The clinician was able to continue through the error messages and proceeded to mark the main carina.After this, the lesion overlay was initially displayed on the fluoro video during procedure; however, as soon as the clinician made his first isocenter adjustment, the overlay disappeared and never came back.He tried multiple viewing angles in an attempt to get the overlay to reappear but it did not.Thus, due to the software error messages and the inability to troubleshoot, the clinician abandoned the use of the lungvision system and utilized the monarch auris system to complete the procedure.Though the device software malfunctioned, the clinician was able to complete the procedure with no injury to the patient.However, as a result of the software errors, the patient experienced a delay in their procedure which caused them to have additional exposure time to radiation and additional time under anesthesia.Specifically, the patient experienced added radiation of 0.084msv; added radiation time of 54 seconds and added sedation time of 3min 52 seconds (3:52min).Despite the additional radiation exposure and anesthesia/sedation time being minimal, body vision medical ltd.Is filing this adverse event report in an abundance of caution.Additionally, it is noted that as part of the lungvision system's risk management file and through a clinical study ("radiation exposure during bronchoscopic procedure guided by lungvision, novel endobronchial navigation and guidance system"), body vision medical ltd.Has evaluated the radiation exposure levels to both the patients and physicians in order to understand the potential risks related to the procedure and utilization of the lungvision system during these fluoroscopic procedures.Body vision medical has found that in comparison to other similar procedures, such as ct-guided lung biopsy, the additional radiation exposure with the lungvision system in this case (0.112msv added) or any case (2.76 ± 2.19 msv as found during 2018 clinical study), is significantly less than the ct-guided lung biopsy (14.5 msv, as reported in "comparison of cone-beam ct-guided and ct fluoroscopy-guided transthoracic needle biopsy of lung nodules." rotolo et al;.Eur radial.2016 feb;26(2):381-9).Thus, in conclusion, though the software malfunctioned and caused additional time under anesthesia and additional exposure to radiation, the added time and exposure are insignificant in comparison to other procedures utilized for the same intended use.As noted, body vision medical ltd.Is filing this adverse event report in an abundance of caution.
Additional Manufacturer Narrative
After successfully completing the first procedure of the day, dr.(b)(6) was waiting for the procedure application to finish processing the case data and close.While waiting for this process to complete the clinician performed the hard shutdown of the tablet and then restarted it without restarting the whole system, including tablet and main unit, as recommended by vendor.This caused the tablet and main unit to become out of sync in the subsequent two cases that day.During cases 2 and 3, false cabt error messages were displayed during main carina registration.The clinician was able to continue through the error messages and proceeded to mark the main carina.After this, the lesion overlay was initially displayed on the fluoro video during procedure; however, as soon as the clinician made his first isocenter adjustment, the overlay disappeared and never came back.He tried multiple viewing angles in an attempt to get the overlay to reappear but it did not.Thus, due to the software error messages and the inability to troubleshoot, the clinician abandoned the use of the lungvision system and utilized the monarch auris system to complete the procedure.Though the device software malfunctioned, the clinician was able to complete the procedure with no injury to the patient.However, as a result of the software errors, the patient experienced a delay in their procedure which caused them to have additional exposure time to radiation and additional time under anesthesia.Specifically, the patient experienced added radiation of 0.084msv; added radiation time of 54 seconds and added sedation time of 3min 52 seconds (3:52min).Despite the additional radiation exposure and anesthesia/sedation time being minimal, body vision medical ltd.Is filing this adverse event report in an abundance of caution.Additionally, it is noted that as part of the lungvision system's risk management file and through a clinical study ("radiation exposure during bronchoscopic procedure guided by lungvision, novel endobronchial navigation and guidance system"), body vision medical ltd.Has evaluated the radiation exposure levels to both the patients and physicians in order to understand the potential risks related to the procedure and utilization of the lungvision system during these fluoroscopic procedures.Body vision medical has found that in comparison to other similar procedures, such as ct-guided lung biopsy, the additional radiation exposure with the lungvision system in this case (0.112msv added) or any case (2.76 ± 2.19 msv as found during 2018 clinical study), is significantly less than the ct-guided lung biopsy (14.5 msv, as reported in "comparison of cone-beam ct-guided and ct fluoroscopy-guided transthoracic needle biopsy of lung nodules." rotolo et al;.Eur radial.2016 feb;26(2):381-9).Thus, in conclusion, though the software malfunctioned and caused additional time under anesthesia and additional exposure to radiation, the added time and exposure are insignificant in comparison to other procedures utilized for the same intended use.As noted, body vision medical ltd.Is filing this adverse event report in an abundance of caution.

• Brand Name: LUNG VISION SYSTEM
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): BODY VISION MEDICAL, LTD.; 7 hamada st.; herzliya 46733 41; IS 4673341
• Manufacturer (Section G): BODY VISION MEDICAL LTD.; 7 hamada st.; herzliya 46733 41; IS 4673341
• Manufacturer Contact: benny krauz ; 7 hamada st.; herzliya 46733-41 ; IS 4673341
• MDR Report Key: 15114368
• Report Number: 3014491269-2022-00002
• Device Sequence Number: 17540298
• Product Code: LLZ
• UDI-Device Identifier: 07290017652085
• UDI-Public: 7290017652085
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LV105502
• Device Lot Number: LV21003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown