DISPOSABLE DISTAL ATTACHMENT D-201-12704 (REF N3529240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170453878), received between Jan 3, 2024 and Feb 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THE OLYMPUS DISPOSABLE DISTAL ATTACHMENT FELL OFF INSIDE THE PATIENT'S BODY DURING A DIAGNOSTIC PROCEDURE. THE DEVICE WAS COLLECTED IMMEDIATELY USING A COLLECTION DEVICE AND THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THE RECOVERED DISTAL ATTACHMENT WAS NOTED TO HAVE CRACKS. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684655 ↗
• InjuryFeb 7, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THE OLYMPUS DISPOSABLE DISTAL ATTACHMENT FELL OFF INSIDE THE PATIENT'S BODY DURING A DIAGNOSTIC PROCEDURE. THE DEVICE WAS COLLECTED IMMEDIATELY USING A COLLECTION DEVICE AND THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THE RECOVERED DISTAL ATTACHMENT WAS NOTED TO HAVE CRACKS. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658081 ↗
• InjuryJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISPOSABLE DISTAL ATTACHMENT FELL OUT WITHIN THE PATIENT'S BODY IMMEDIATELY AFTER INSERTION. THE FALLEN ITEM WAS RECOVERED, AND THE UNSPECIFIED PROCEDURE WAS COMPLETED WITH SIMILAR EQUIPMENT. THERE WAS NO EFFECT TO THE PATIENT. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT. AT THE TIME OF INSPECTION BEFORE USE, THE DEVICE REPORTEDLY FELT LOOSE, AND EVEN THOUGH IT WAS FIRMLY ATTACHED, THE ABOVE ISSUE OCCURRED. AFTER CHECKING WITH THE PERSON IN CHARGE OF THE FACILITY, THEY ALSO CHECKED OTHER IDENTICAL PRODUCTS, BUT ONLY THE ACTUAL PRODUCT WAS FOUND TO BE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435711 ↗