LungVision Tool Bridge (REF LV2055004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017652061), received between Oct 11, 2023 and Oct 11, 2023 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED, "PROPHYLACTIC EPINEPHRINE ATTENUATES SEVERE BLEEDING IN LUNG TRANSPLANTATION PATIENTS UNDERGOING TRANSBRONCHIAL LUNG BIOPSY: RESULTS OF THE PROPHET RANDOMIZED TRIAL." BACKGROUND: SEVERE HEMORRHAGE IS AN UNCOMMON YET POTENTIALLY LIFE-THREATENING COMPLICATION OF TRANSBRONCHIAL LUNG BIOPSY. LUNG TRANSPLANTATION RECIPIENTS UNDERGO MULTIPLE BRONCHOSCOPIES WITH BIOPSY AND ARE CONSIDERED TO BE AT AN INCREASED RISK FOR BLEEDING FROM TRANSBRONCHIAL BIOPSY, INDEPENDENT OF TRADITIONAL RISK FACTORS. WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF ENDOBRONCHIAL ADMINISTRATION OF PROPHYLACTIC TOPICAL EPINEPHRINE IN ATTENUATING TRANSBRONCHIAL BIOPSY-RELATED HEMORRHAGE IN LUNG TRANSPLANT RECIPIENTS. METHODS: THE PROPHYLACTIC EPINEPHRINE FOR THE PREVENTION OF TRANSBRONCHIAL LUNG BIOPSY-RELATED BLEEDING IN LUNG TRANSPLANT RECIPIENTS STUDY WAS A 2-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL. PARTICIPANTS UNDERGOING TRANSBRONCHIAL LUNG BIOPSY WERE RANDOMIZED TO RECEIVE 1:10,000-DILUTED TOPICAL EPINEPHRINE VS SALINE PLACEBO ADMINISTERED PROPHYLACTICALLY INTO THE TARGET SEGMENTAL AIRWAY. BLEEDING WAS GRADED BASED ON A CLINICAL SEVERITY SCALE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumonia; Pneumothorax; Respiratory Failure

  MAUDE report 17912193 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED, "PROPHYLACTIC EPINEPHRINE ATTENUATES SEVERE BLEEDING IN LUNG TRANSPLANTATION PATIENTS UNDERGOING TRANSBRONCHIAL LUNG BIOPSY: RESULTS OF THE PROPHET RANDOMIZED TRIAL." BACKGROUND: SEVERE HEMORRHAGE IS AN UNCOMMON YET POTENTIALLY LIFE-THREATENING COMPLICATION OF TRANSBRONCHIAL LUNG BIOPSY. LUNG TRANSPLANTATION RECIPIENTS UNDERGO MULTIPLE BRONCHOSCOPIES WITH BIOPSY AND ARE CONSIDERED TO BE AT AN INCREASED RISK FOR BLEEDING FROM TRANSBRONCHIAL BIOPSY, INDEPENDENT OF TRADITIONAL RISK FACTORS. WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF ENDOBRONCHIAL ADMINISTRATION OF PROPHYLACTIC TOPICAL EPINEPHRINE IN ATTENUATING TRANSBRONCHIAL BIOPSY-RELATED HEMORRHAGE IN LUNG TRANSPLANT RECIPIENTS. METHODS: THE PROPHYLACTIC EPINEPHRINE FOR THE PREVENTION OF TRANSBRONCHIAL LUNG BIOPSY-RELATED BLEEDING IN LUNG TRANSPLANT RECIPIENTS STUDY WAS A 2-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL. PARTICIPANTS UNDERGOING TRANSBRONCHIAL LUNG BIOPSY WERE RANDOMIZED TO RECEIVE 1:10,000-DILUTED TOPICAL EPINEPHRINE VS SALINE PLACEBO ADMINISTERED PROPHYLACTICALLY INTO THE TARGET SEGMENTAL AIRWAY. BLEEDING WAS GRADED BASED ON A CLINICAL SEVERITY SCALE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumonia; Pneumothorax; Respiratory Failure

  MAUDE report 17912164 ↗