Single Use Reloadable Clip Applicator HX-810UR (REF N5432940)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
All models of Single Use Reloadable Clip Applicator (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170421341), received between Jun 7, 2022 and Jun 20, 2025 — classified as 5 malfunctions.
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
- Material Deformation1
- Mechanical Jam1
- Separation Failure1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 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 1 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298551 ↗MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS OBTAINED REGARDING THE EVENT: - THE REPORTABLE MALFUNCTION OCCURRED DURING A DIAGNOSTIC COLONOSCOPY, HEMOSTASIS AFTER THERAPEUTIC POLYPECTOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE. SINCE THE CLIP COULD NOT BE PLACED, THE MUCOSA WAS NOT GRASPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18166438 ↗MalfunctionNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT THE CLIP ON THE SINGLE USE RELOADABLE CLIP APPLICATOR COULD NOT BE RELEASED, AS THE WIRES BECOME LOOSE DURING THE CLIP SET UP. THE CUSTOMER ALSO MENTIONED THAT THE 2YK CHARGER WAS AFFECTED. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150751 ↗MalfunctionJun 23, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
THE CUSTOMER REPORTED THAT THE HANDLE OF THE SUBJECT DEVICE WAS DEFORMED DURING A POLYPECTOMY PROCEDURE. AFTER THE FIRST CLIP WAS SUCCESSFULLY DEPLOYED, THE SECOND CLIP CAUSED A JAM AND THE CLOSING FORCE DEFORMED AND BENT THE HANDLE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND TWO NEW CLIPS. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14787526 ↗MalfunctionJun 7, 2022Use of Device Problem; Use of Device Problem
AS REPORTED, " WHEN A SALES REPRESENTATIVE VISITED THE FACILITY, THE DISPOSABLE PRODUCT WAS EOG (ETHYLENE OXIDE GAS) STERILIZED AND REUSED. CURRENTLY, NO HEALTH HAZARDS HAVE BEEN REPORTED TO PATIENTS. ACCORDING TO REPORTER, THE USAGE PERIOD IS LESS THAN ONE MONTH (USED IT REPEATEDLY ABOUT 3 TO 4 TIMES). THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14623406 ↗
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- MANTIS™ Clip M00521420Boston Scientific Corporation · Hemostatic metal clip for the GI tract195 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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