Single Use Reloadable Clip ApplicatorRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Single Use Reloadable Clip Applicator by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2022 and Sep 17, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Single Use Reloadable Clip Applicator problems
Device problems
- Separation Failure15
- Detachment of Device or Device Component6
- Failure to Disconnect2
- Mechanical Jam2
- Difficult or Delayed Separation1
- Failure to Fire1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Single Use Reloadable Clip Applicator models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Reloadable Clip Applicator HX-810URHemostatic Metal Clip For The Gi Tract21 reports
- Single Use Reloadable Clip Applicator HX-810URHemostatic Metal Clip For The Gi Tract5 reports
- Single Use Reloadable Clip Applicator HX-810LRHemostatic Metal Clip For The Gi Tract3 reports
Recent Single Use Reloadable Clip Applicator adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2025Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073681 ↗MalfunctionSep 17, 2025Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073413 ↗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 5 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299142 ↗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 ↗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 2 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298782 ↗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 ↗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 ↗MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697485 ↗MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697358 ↗MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697291 ↗MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697170 ↗MalfunctionFeb 4, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED, THE SINGLE USE RELOADABLE CLIP APPLICATOR WHILE TRYING TO "SHOOT", THE APPLICATOR GOT STUCK ON THE CLIP. WHEN IT WAS PULLED BACK, THE CLIP WAS PULLED OUT OF THE WOUND AGAIN. THE CUSTOMER ALSO STATED THIS HAS NOT HAPPENED PRIOR BEFORE BUT OCCURRED WITH THREE DIFFERENT CLIP APPLICATORS. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 4 REPORTS FOR 4 DIFFERENT CLIP APPLICATORS. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #1. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #2. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #3. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #4. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18637742 ↗MalfunctionNov 21, 2023Failure to Disconnect; Failure to Disconnect
THE CUSTOMER REPORTED THE ISSUE WAS DETECTED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE CUSTOMER REPORTED THE PROCEDURE WAS NOT PROLONGED OR DELAYED TO A CLINICALLY RELEVANT EXTENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18184865 ↗MalfunctionNov 21, 2023Mechanical Jam; Mechanical Jam
THE CUSTOMER REPORTED TO OLYMPUS THAT THE RELOADABLE CLIP APPLICATOR CLIP CAN'T RELEASED BECAUSE THE WIRE CAME LOOSE DURING THE CLIP SETUP. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (POLYPECTOMY) AND DIAGNOSTIC (COLONOSCOPY). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18179873 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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