MAUDE Adverse Event Report: BODY VISION MEDICAL LTD. LUNGVISION TOOL

Model Number	BRIDGE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Though the device did not malfunction, because the sheath was damaged, a marker was dislodged and has to be removed from the patient, body vision medical ltd.Is submitting this report to the fda in an abundance of caution.This is the first report of this nature.
Event or Problem Description
During a procedure, while using the lungvision tool sheath component it was noticed that a radiopaque marker, one of the sheath component was dislodged from the sheath into the right lower lobe of the patient's lungs.

• Brand Name: LUNGVISION TOOL
• Common Device Name: LUNGVISION TOOL
• Manufacturer (Section D): BODY VISION MEDICAL LTD.; 34 sokolov st.; ramat hasharon 4723503, ; IS
• Manufacturer (Section G): BODY VISION MEDICAL LTD.; 34 sokolov st.; ramat hasharon 4723503, ; IS
• Manufacturer Contact: benny krauz ; 34 sokolov st; ramat hasharon 4723503, ; IS
• MDR Report Key: 12860051
• Report Number: 3014491269-2021-00001
• Device Sequence Number: 4292876
• Product Code: EOQ
• UDI-Device Identifier: 07290017652092
• UDI-Public: 7290017652092
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: BRIDGE
• Device Catalogue Number: LV2055010
• Device Lot Number: LVT210107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male