Colored Short Clip HX-610-090SCRecalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
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 04953170200397), received between Dec 19, 2023 and Jan 8, 2025 — classified as 2 injuries, 1 malfunction.
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. 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
- Detachment of Device or Device Component2
- Device Reprocessing Problem1
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.
InjuryJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE SOME DELAYS WITH THE PROCEDURE BUT THE DETAILS WERE UNKNOWN. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21107352 ↗InjurySep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A PROCEDURE FOR MARKING PURPOSES, WHEN THE COLORED SHORT CLIP WAS LOADED AND THE CLIP BULLET WAS REMOVED FROM THE SHEATH INSIDE THE BODY, THE CLIP FELL OFF. THE FALLEN PIECES (METAL PART AND CLIP CASE) WERE COLLECTED. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE DEVICE. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314248 ↗MalfunctionDec 19, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING SURGERY, A PREVIOUSLY USED OLYMPUS YELLOW CLIP (SINGLE USE ROTATABLE CLIP FIXING DEVICE) CAME OUT FROM THE COLONOVIDEOSCOPE. THE ISSUE WAS FOUND AT AN UNSPECIFIED PROCEDURE. THE CLIP WAS RECOVERED, AND THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18355811 ↗
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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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