Single Use Reloadable Clip Applicator HX-810LRRecalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
All models of Single Use Reloadable Clip Applicator (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04953170390692), received between Apr 3, 2024 and Jun 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Failure2
- Difficult or Delayed Separation1
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.
MalfunctionJun 20, 2025Separation Failure; Separation Failure
IT WAS REPORTED DURING CLIP PLACEMENT THE SHEATH COMES OFF AND THE CLIP ITSELF IS NOT RELEASED THE EVENT WAS REPEATED BOTH THE DAY BEFORE AND ON FRIDAY OUT OF 5 TOTAL CLIP-LAYERS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. REPORT 4 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299046 ↗MalfunctionJun 20, 2025Separation Failure; Separation Failure
IT WAS REPORTED DURING CLIP PLACEMENT THE SHEATH COMES OFF AND THE CLIP ITSELF IS NOT RELEASED THE EVENT WAS REPEATED BOTH THE DAY BEFORE AND ON FRIDAY OUT OF 5 TOTAL CLIP-LAYERS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. REPORT 3 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298929 ↗MalfunctionApr 3, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THE CLIP APPLICATOR HAD SOME ISSUES DISENGAGING THE CLIPS DURING EVERY CLIP, ONCE IT WAS CLIPPED, IT DID NOT DISENGAGE IMMEDIATELY. THE ISSUE OCCURRED DURING A PER-ORAL ENDOSCOPIC MYOTOMY PROCEDURE AND WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034458 ↗
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- colonic FTRD Set 14Ovesco Endoscopy AG · Hemostatic Metal Clip For The Gi Tract2 deaths95 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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