Single Use Rotatable Clip Fixing Device HX-201LR-135 (UDI 04953170192999)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
All models of Single Use Rotatable Clip Fixing Device (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170192999), received between May 16, 2023 and May 16, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE AUTHOR CONFIRMS THERE WERE NO OLYMPUS DEVICE MALFUNCTION AND NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT ADVERSE EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury
MAUDE report 16938970 ↗
Other Ligator, esophageal devices
- Speedband Superview Super 7 M00542250Boston Scientific Corporation · Ligator, esophageal6 deaths4,728 reports
- Saeed G22692Cook Incorporated · Ligator, esophageal295 reports
- Saeed G22553Cook Incorporated · Ligator, esophageal289 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal1 recall239 reports
- Saeed G31917Cook Incorporated · Ligator, esophageal123 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal97 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135Olympus Medical Systems Corp. · Ligator, esophageal1 recall1 death10 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135LOlympus Medical Systems Corp. · Ligator, esophageal1 recall8 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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