Olympus ARV120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019778008660), received between Apr 19, 2024 and Apr 19, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING THE COLONOSCOPY SCREENING, THE ARV120 ENDOCUFF FELL OFF A SCOPE INTO THE PATIENT'S SIGMOID COLON. THE ENDOCUFF WAS SUCCESSFULLY REMOVED WITH FORCEPS. A PROCEDURAL DELAY OCCURRED BUT NOT MORE THAN 30 MINUTES AND THE PATIENT WAS NOT UNDER ANESTHESIA. THE OUTCOME OF THE PROCEDURE WAS NOT AFFECTED AS A RESULT OF THE ISSUE AND THERE WAS NO UNPLANNED DIAGNOSTIC IMAGING NEEDED TO LOCATE THE DEVICE AND CONFIRM IT WAS REMOVED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY DUE TO POOR COLONOSCOPY PREP. THE METHOD USED TO ATTACHED THE ENDOCUFF WAS BY PUSHING IT ON TO THE END OF THE SCOPE. THE DEVICE WAS INSPECTED BEFORE USE AND DID NOT APPEAR BROKEN, CRACKED, OR DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142836 ↗
• InjuryApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING THE COLONOSCOPY SCREENING, THE ARV120 ENDOCUFF FELL OFF A SCOPE INTO THE PATIENT'S SIGMOID COLON. THE ENDOCUFF WAS SUCCESSFULLY REMOVED WITH FORCEPS. A PROCEDURAL DELAY OCCURRED BUT NOT MORE THAN 30 MINUTES AND THE PATIENT WAS NOT UNDER ANESTHESIA. THE OUTCOME OF THE PROCEDURE WAS NOT AFFECTED AS A RESULT OF THE ISSUE AND THERE WAS NO UNPLANNED DIAGNOSTIC IMAGING NEEDED TO LOCATE THE DEVICE AND CONFIRM IT WAS REMOVED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY DUE TO POOR COLONOSCOPY PREP. THE METHOD USED TO ATTACHED THE ENDOCUFF WAS BY PUSHING IT ON TO THE END OF THE SCOPE. THE DEVICE WAS INSPECTED BEFORE USE AND DID NOT APPEAR BROKEN, CRACKED, OR DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142822 ↗