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

Model Number	LV2055011
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Lung biopsy was performed using forceps and a bodyvision lungvision tool kit on (b)(6) 2023.The physician does not recall any difficulties or immediate complications, no sharp angles of the catheter and no difficulty advancing the tool.Upon completion of the biopsy pathology, it was determined that there was lung inflammation.This patient, underwent an additional pet scan and it was determined that another lung biopsy was required.During this additional biopsy procedure, the physician found retained material suspected to be from the bodyvision device.Bodyvision became aware of this event on march 07, 2023.
Additional Manufacturer Narrative
The device was not retained for evaluation.We strongly suspect, following a review of the procedure fluro video, that the biopsy forceps jaws used by the health professional were opened inside the lungvision tool sheath before emerging from the sheath distal tip, which harmed and damaged the sheath inner liner.Because the forceps damaged the inner liner of the sheath, this contributed to the device malfunction and event.

• Brand Name: LUNGVISION TOOL
• Common Device Name: EOQ
• Manufacturer (Section D): BODY VISION MEDICAL LTD.; 7 hamada st.; herzlyia, 46733 41; IS 4673341
• Manufacturer (Section G): BODY VISION MEDICAL LTD.; 7 hamada st.; herzlyia, 46733 41; IS 4673341
• Manufacturer Contact: benny krauz ; 7 hamada st.; herzlyia, 46733-41 ; IS 4673341
• MDR Report Key: 16626697
• Report Number: 3014491269-2023-00001
• Device Sequence Number: 17271088
• Product Code: EOQ
• UDI-Device Identifier: 07290017652108
• UDI-Public: 7290017652108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/27/2023

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 Expiration Date: 12/04/2023
• Device Model Number: LV2055011
• Device Lot Number: LVT220108
• 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: 03/07/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2022
• 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