Olympus ARV130Recalls & reported problems
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019778008677), received between Mar 5, 2026 and Apr 17, 2026 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
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.
MalfunctionApr 17, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BASE OF THE ENDOCUFF VISION PURPLE SPLITS WHEN BEING APPLIED ONTO A PAEDIATRIC SCOPE, WEAKENING THE INTEGRITY OF THE ATTACHMENT. THE CUFF FULLY SPLIT AND CAME OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24918125 ↗MalfunctionApr 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE ENDOCUFF VISION WAS MISSING FROM THE COLON DURING A DIAGNOSTIC PROCEDURE. THIS OCCURRED WHILE THE PATIENT WAS SEDATED AND THE DEVICE WAS INSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816823 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THE ENDOCUFF VISION PRESENTED AN ENDOCUFF-PHALANGE THAT WAS SEPARATED FROM THE CUFF. THE ISSUE OCCURRED DURING A PROCEDURE. THE PROCEDURE PROLONGED LESS THAN 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24527418 ↗
Other Endoscopic Access Overtube, Gastroenterology-Urology devices
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- Trokamed WA2PS20STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS20LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS18LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Trokamed WA2PS18STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Navigator HD M0062502220Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology1 death31 reports
- Navigator HD M0062502230Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology29 reports
- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.