EVIS EXERA PLEURAVIDEOSCOPE OLYMPUS LTF TYPE 160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170340284), received between Apr 11, 2022 and Sep 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810133 ↗
• MalfunctionMar 2, 2026Microbial Contamination of Device

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485580 ↗
• MalfunctionJul 2, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE VIDEOSCOPE EXHIBITED THE ADHESIVE ON THE BENDING SECTION HAS FOREIGN OBJECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662193 ↗
• MalfunctionSep 30, 2022Contamination; Contamination

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REGARDING THE REPORTED EVENT (DAMAGED BENDING SECTION AND LEAKAGE FROM A-RUBBER): THE REPORTED ISSUE WAS OBSERVED WHILE REPROCESSING THE SUBJECT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513947 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "BEDSIDE PLEUROSCOPY IN THE INTENSIVE CARE UNIT" BY HEAN OOI. THIS STUDY RETROSPECTIVELY ANALYZED THE DATA FROM A CONSECUTIVE CASE SERIES, AND EXAMINED THE COMPLICATIONS AND OUTCOMES FOLLOWING BEDSIDE PLEUROSCOPY IN PATIENTS WITH UNDIAGNOSED PLEURAL EFFUSION WITH ACUTE RESPIRATORY FAILURE. A TOTAL OF 25 PATIENTS UNDERWENT PLEUROSCOPIC PROCEDURES AT THE BEDSIDE, AND WERE ROUTINELY MONITORED AND RECORDED FOR ANY MAJOR AND MINOR COMPLICATIONS. THE STUDY REPORTED THAT FIFTEEN PATIENTS (60%) HAD MALIGNANCIES, OF WHOM 11 HAD LUNG CANCER, AND ONE EACH HAD BREAST CANCER, ESOPHAGEAL CANCER, HEPATOMA, AND A MALIGNANT MEDIASTINAL TUMOR. A TOTAL OF 11 (44%) PATIENTS SUFFERED ANY COMPLICATIONS, BUT NO MAJOR COMPLICATIONS WERE REPORTED. THE STUDY CONCLUDED THAT THE PLEUROSCOPY PERFORMED AT THE BEDSIDE IN AN ICU WITH LOCAL ANALGESIA WAS AN EASY AND WELL-TOLERATED PROCEDURE, AND COULD BE USED FOR PATIENTS IN CRITICAL CONDITION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: SUBCUTANEOUS EMPHYSEMA - (3): ALL PATIENTS HAD 16 F PIG-TAIL CATHETER DRAINS AFTER THE PROCEDURE THROUGH THE SAME ENTRY PORT AS THE PLEUROSCOPY TO AVOID THE SPREAD OF SUBCUTANEOUS EMPHYSEM

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Respiratory Problem

  MAUDE report 14073644 ↗