KEYBOARD MAJ-1710Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170264955), received between Jun 28, 2024 and Jun 28, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “No Display/Image” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Display/Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A RADIAL ENDOSCOPIC BRONCHIAL ULTRASOUND (EBUS), THE LCD SCREEN OF THE SUBJECT DEVICE WAS NOT WORKING. THE CUSTOMER DID NOT HAVE ANY OTHER KEYBOARD OR ANOTHER (EU-ME1) DEVICE TO TRY. THEY ALREADY POWER CYCLED THE (EI-ME1) DEVICE AND RESEATED THE KEYBOARD AND GOT THE SAME ISSUE. THE EBUS WAS PERFORMED AS AN ELECTIVE SURGERY FOR A MEDIASTINAL NODE BIOPSY. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TAKEN OFF OF GENERAL ANESTHESIA. THE PROCEDURE HAS BEEN RESCHEDULED FOR A LATER DATE BUT NOT YET COMPLETED. ABORTING THE PROCEDURE DID NOT RESULT IN ANY HARM OR DELAYED TREATMENT OR DIAGNOSIS OF A LIFE-THREATENING CONDITION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638747 ↗InjuryJun 28, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A RADIAL ENDOSCOPIC BRONCHIAL ULTRASOUND (EBUS), THE LCD SCREEN OF THE SUBJECT DEVICE WAS NOT WORKING. THE CUSTOMER DID NOT HAVE ANY OTHER KEYBOARD OR ANOTHER (EU-ME1) DEVICE TO TRY. THEY ALREADY POWER CYCLED THE (EI-ME1) DEVICE AND RESEATED THE KEYBOARD AND GOT THE SAME ISSUE. THE EBUS WAS PERFORMED AS AN ELECTIVE SURGERY FOR A MEDIASTINAL NODE BIOPSY. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TAKEN OFF OF GENERAL ANESTHESIA. THE PROCEDURE HAS BEEN RESCHEDULED FOR A LATER DATE BUT NOT YET COMPLETED. ABORTING THE PROCEDURE DID NOT RESULT IN ANY HARM OR DELAYED TREATMENT OR DIAGNOSIS OF A LIFE-THREATENING CONDITION FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638744 ↗
Other Endoscopic ultrasound system, gastroenterology-urology devices
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- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX EG-3670URKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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