Rotatable Clip Fixing DeviceRecalls & 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
- 48
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 3 models of Rotatable Clip Fixing Device by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2019 and May 20, 2025 — classified as 13 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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 Rotatable Clip Fixing Device problems
Device problems
- Peeled/Delaminated15
- Adverse Event Without Identified Device or Use Problem8
- Difficult to Remove4
- Failure to Clean Adequately3
- Activation Failure2
- Contamination2
- Mechanical Jam2
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Hemorrhage/Blood Loss/Bleeding9
- Perforation5
- Tissue Damage2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- Unspecified Tissue Injury1
Rotatable Clip Fixing Device models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rotatable Clip Fixing Device HX-110QRLigator, esophageal26 reports
- Rotatable Clip Fixing Device HX-110URLigator, esophageal14 reports
- Rotatable Clip Fixing Device HX-110LRLigator, esophageal8 reports
Recent Rotatable Clip Fixing Device adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC MARKING (EMR) FOR COLON SURGERY, FOR PERFORMING A MEASURE OF HEMOSTASIS, THE ROTATABLE CLIP SLIDER DEVICE (HX-110QR) WAS ABLE TO BE OPERATED. HOWEVER, THE CLIP (HX-610-135) DID NOT CLOSE AND THE BULLET WAS OPENED. THE CLIP (HX-610-135) COULD NOT BE REMOVED FROM THE ROTATABLE CLIP SLIDER (HX-110QR). IT WAS ATTEMPTED TO CONFIRM WHAT SPECIFIC AREA WAS GETTING CAUGHT AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT INCLUDES (2) REPORTS. THIS IS REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052765 ↗MalfunctionMay 15, 2025Separation Problem; Separation Problem
NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031297 ↗InjuryJan 21, 2025Separation Failure; Separation Failure
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THERE WAS NO FURTHER MEDICAL INTERVENTION OR TREATMENT PERFORMED WITH THE POTENTIAL FOREIGN BODY LEFT IN THE PATIENT'S LARGE INTESTINE. THE CUSTOMER CONFIRMED NO FURTHER PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 21202958 ↗MalfunctionNov 25, 2024Material Too Rigid or Stiff; Activation Failure; Material Too Rigid or Stiff; Activation Failure
IT WAS REPORTED, THE ROTATABLE CLIP FIXING DEVICE HAD A CLIP WAS DIFFICULT TO HIT. AND THE HANDLE BECAME QUITE STIFF PARTWAY THROUGH. THE ISSUE OCCURRED, DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20776068 ↗MalfunctionOct 28, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THE ROTATABLE CLIP FIXING DEVICE¿S CONTROL WIRE TIP BLACK COATING WAS PEELING. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20553490 ↗MalfunctionOct 7, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THE ROTATABLE CLIP FIXING DEVICE GRIPPED THE MUCOUS MEMBRANE AND COULD NOT BE RELEASED. THE DOCTOR REMOVED THE CLIP FROM THE APPLICATOR BY HAND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391179 ↗MalfunctionSep 27, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ROTATABLE CLIP FIXING DEVICE EXHIBITED OPERATING WIRE COATING OF APPLICATOR PEELED OFF AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322523 ↗MalfunctionSep 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE ROTATABLE CLIP FIXING DEVICE OPERATING WIRE WAS PEELED AND DISLODGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268296 ↗MalfunctionAug 14, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE ROTATABLE CLIP FIXING EXPERIENCED DIFFICULTY REMOVING THE CLIP GRIPPING THE MUCOSA FROM THE APPLICATOR, IT WAS EVENTUALLY REMOVED BY SHAKING IT. THIS ISSUE OCCURRED DURING A THERAPEUTIC COLON POLYPECTOMY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19985894 ↗MalfunctionAug 8, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE ROTATABLE CLIP FIXING DEVICE EXHIBITED AN ISSUE WERE THE CLIP GRIPPING THE MUCOSA COULD NOT BE REMOVED FROM THE APPLICATOR. HOWEVER, IT WAS SUBSEQUENTLY REMOVED BY SHAKING IT. THE ISSUE WAS FOUND DURING A THERAPEUTIC COLON POLYPECTOMY PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS COMPLAINT IS RELATED TO (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19943690 ↗MalfunctionJul 12, 2024Material Fragmentation; Peeled/Delaminated; Material Fragmentation; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ROTATABLE CLIP FIXING DEVICE HAD EXHIBITED THE COATING OF THE OPERATION WIRE WAS PEELED OFF AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19733468 ↗MalfunctionJun 10, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE ROTATABLE CLIP FIXING DEVICE HAD PROBLEMS CAUSED BY IMPROPER REPROCESSING (FOREIGN MATTER). THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19499585 ↗MalfunctionMay 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355308 ↗MalfunctionMay 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355297 ↗MalfunctionMay 20, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED AND FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355285 ↗
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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