PROBE DRIVING UNIT MAJ-1720 (UDI 04953170355684)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170355684), received between Jan 27, 2022 and Aug 22, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

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.

• InjuryAug 22, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE UNDER GENERAL ANESTHESIA, THE PROBE WAS NOT SPINNING WHILE PROBE CONNECTED TO PROBE DRIVING UNIT. THE INTENDED PROCEDURE WAS FOR DIAGNOSING CANCER AND THE PROVIDER WAS UNABLE TO OBTAIN DIAGNOSIS WITH THE DEVICE. THEREFORE, THE PROCEDURE WAS COMPLETED BY SWITCHING TO FLUOROSCOPY AND WAS PROLONGED FOR MORE THAN 30 MINUTES. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877861 ↗
• InjuryAug 22, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE UNDER GENERAL ANESTHESIA, THE PROBE WAS NOT SPINNING WHILE PROBE CONNECTED TO PROBE DRIVING UNIT. THE INTENDED PROCEDURE WAS FOR DIAGNOSING CANCER AND THE PROVIDER WAS UNABLE TO OBTAIN DIAGNOSIS WITH THE DEVICE. THEREFORE, THE PROCEDURE WAS COMPLETED BY SWITCHING TO FLUOROSCOPY AND WAS PROLONGED FOR MORE THAN 30 MINUTES. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877834 ↗
• InjuryFeb 3, 2025Break; Poor Quality Image; Break; Poor Quality Image

  THERE WAS NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298271 ↗
• InjuryFeb 3, 2025Break; Poor Quality Image; Break; Poor Quality Image

  IT WAS REPORTED THAT THE PROBE DRIVING UNIT'S SOCKET IS BROKEN AND THE IMAGE IS DARK. THE ION ENDOBRONCHIAL ULTRASOUND UNDER GENERAL ANESTHESIA WAS PROLONGED FOR OVER 30 MINUTES DUE TO SWITCHING OF RADIAL PROBES WITH THE UNIT AND NEEDING TO HAVE A BIOMED TECHNICIAN COME UP TO ASSIST WITH TROUBLESHOOTING DURING THE CASE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298166 ↗
• MalfunctionJan 27, 2022No Display/Image; No Display/Image

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING PROCEDURE, THE PROBE DRIVING UNIT HAD NO ULTRASOUND IMAGE WAS DISPLAYED ON THE MONITOR. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13371725 ↗