ULTRASOUND CABLE MAJ-2056Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-2056 DETACHABLE CABLE FOR EUS&EBUS S · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170355677), received between Jul 2, 2024 and Mar 27, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708710 ↗InjuryJul 2, 2024Material Separation; Material Separation
IT WAS REPORTED THAT DURING A DIAGNOSTIC ION ROBOTIC BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND WITH CONE BEAM, (BRONCHOSCOPY WITH BIOPSY/ FLEXIBLE BRONCHOSCOPY), THE SLEEVE AROUND THE ULTRASOUND CABLE, WAS WORN OFF COMPLETELY AND THE WIRING WAS VISIBLE (POOR APPEARANCE). THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE AND PROCEDURE DELAYED BY 45 MINUTES AND SO WAS PATIENT¿S ANESTHESIA. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656403 ↗InjuryJul 2, 2024Material Separation; Material Separation
IT WAS REPORTED THAT DURING A DIAGNOSTIC ION ROBOTIC BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND WITH CONE BEAM, (BRONCHOSCOPY WITH BIOPSY/ FLEXIBLE BRONCHOSCOPY), THE SLEEVE AROUND THE ULTRASOUND CABLE, WAS WORN OFF COMPLETELY AND THE WIRING WAS VISIBLE (POOR APPEARANCE). THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE AND PROCEDURE DELAYED BY 45 MINUTES AND SO WAS PATIENT¿S ANESTHESIA. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656297 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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