EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170343490), received between Jul 3, 2024 and Jul 3, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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.

• InjuryJul 3, 2024No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DURING A DIAGNOSTIC EBUS-TBNA (ENDOBRONCHIAL ULTRASOUND GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION) PROCEDURE, PROCESSOR MALFUNCTION OCCURRED, WHERE THE IMAGE FROZE AND ERROR MESSAGE US1605 OCCURRED FOR CELL BOARD MALFUNCTION. AS SUCH, THE PROCEDURE WAS CUT SHORT. THE SAMPLE OBTAINED WAS NOT ENOUGH AND PATIENT MAY NEED TO BE RESCHEDULED. SEVERAL LYMPH NOTED THAT NEEDED TO BE SAMPLED ONLY ONE WAS SAMPLED BEFORE THE MALFUNCTION. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS PLANNED. THE PATIENT NEEDS TO BE RESCHEDULED FOR REPEAT PROCEDURE. ADDITIONAL FOLLOW-UP HAS BEEN REQUESTED BUT UNAVAILABLE THE TIME OF THE REPORT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667400 ↗
• InjuryJul 3, 2024No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DURING A DIAGNOSTIC EBUS-TBNA (ENDOBRONCHIAL ULTRASOUND GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION) PROCEDURE, PROCESSOR MALFUNCTION OCCURRED, WHERE THE IMAGE FROZE AND ERROR MESSAGE US1605 OCCURRED FOR CELL BOARD MALFUNCTION. AS SUCH, THE PROCEDURE WAS CUT SHORT. THE SAMPLE OBTAINED WAS NOT ENOUGH AND PATIENT MAY NEED TO BE RESCHEDULED. SEVERAL LYMPH NOTED THAT NEEDED TO BE SAMPLED ONLY ONE WAS SAMPLED BEFORE THE MALFUNCTION. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS PLANNED. THE PATIENT NEEDS TO BE RESCHEDULED FOR REPEAT PROCEDURE. ADDITIONAL FOLLOW-UP HAS BEEN REQUESTED BUT UNAVAILABLE THE TIME OF THE REPORT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667390 ↗