EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170343414), received between Apr 17, 2019 and Sep 30, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Poor Quality Image” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE ENDOSCOPIC ULTRASOUND CENTER ONLY SHOWED HALF OF THE ULTRASOUND IMAGE DURING A DIAGNOSTIC PROCEDURE WITH PLANNED BIOPSY. AFTER TROUBLESHOOTING, IT SEEMED TO BE A RANDOM AND ONE-TIME OCCURRENCE, AND THE DEVICE SPONTANEOUSLY BEGAN TO SHOW FULL IMAGE. IT WAS DETERMINED THAT THE SUBJECT DEVICE WAS THE CAUSE OF THE ISSUE. THE PROCEDURE WAS CANCELLED WHILE THE PATIENT WAS ON THE TABLE AND ALREADY INTUBATED. THE PATIENT WAS RESCHEDULED A WEEK LATER. THE RESCHEDULED PROCEDURE WAS COMPLETED WITH A LOANER ENDOBRONCHIAL ULTRASOUND SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339751 ↗
• InjurySep 30, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE ENDOSCOPIC ULTRASOUND CENTER ONLY SHOWED HALF OF THE ULTRASOUND IMAGE DURING A DIAGNOSTIC PROCEDURE WITH PLANNED BIOPSY. AFTER TROUBLESHOOTING, IT SEEMED TO BE A RANDOM AND ONE-TIME OCCURRENCE, AND THE DEVICE SPONTANEOUSLY BEGAN TO SHOW FULL IMAGE. IT WAS DETERMINED THAT THE SUBJECT DEVICE WAS THE CAUSE OF THE ISSUE. THE PROCEDURE WAS CANCELLED WHILE THE PATIENT WAS ON THE TABLE AND ALREADY INTUBATED. THE PATIENT WAS RESCHEDULED A WEEK LATER. THE RESCHEDULED PROCEDURE WAS COMPLETED WITH A LOANER ENDOBRONCHIAL ULTRASOUND SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20336948 ↗
• InjuryOct 3, 2019No Display/Image

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE ULTRASOUND IMAGE WAS DARK AND GRAINY. THE PHYSICIAN WAS UNABLE TO VIEW THE ASPIRATION NEEDLE. THE INTENDED PROCEDURE WAS ABORTED. THE USER FACILITY REPORTED THAT THE PATIENT HAD BEEN SEDATED PRIOR TO THE PROCEDURE AND WAS TRANSPORTED TO DIFFERENT HOSPITAL. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9151125 ↗
• InjuryOct 3, 2019Poor Quality Image; Poor Quality Image

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE ULTRASOUND IMAGE WAS DARK AND GRAINY. THE PHYSICIAN WAS UNABLE TO VIEW THE ASPIRATION NEEDLE. THE INTENDED PROCEDURE WAS ABORTED. THE USER FACILITY REPORTED THAT THE PATIENT HAD BEEN SEDATED PRIOR TO THE PROCEDURE AND WAS TRANSPORTED TO DIFFERENT HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 9151124 ↗
• MalfunctionApr 17, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE DISK ACCESS LAMP ON THE FRONT PANEL IS LIT AS ORANGE AND THE SUBJECT EU-ME2 PREMIER PLUS DID NOT START UP, WHEN AN ENDOSCOPIC ULTRASOUND-FINE NEEDLE ASPIRATION (EUS-FNA) WAS STARTED AFTER ANAESTHESIA. THE USER CANCELLED THE INTENDED PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8521834 ↗