LIGATING DEVICE HX-20U-1Recalls & reported problems
Olympus Medical Systems Corp. · HX-20U-1.B DETACH LOOP 2.8MM CHAN 230CM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170044922), received between Feb 23, 2020 and Mar 31, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Ejection Problem” (1 report).
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.
Most reported problems
Device problems
- Ejection Problem1
- Entrapment of Device1
- Failure to Cut1
- Mechanical Jam1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2021Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
THE USER FACILITY REPORTED TO OLYMPUS THAT AFTER PLACING THE LIGATING DEVICE'S ENDOLOOP (FOR REMOVAL OF THE POLYP) DURING A PROCEDURE, THE LOOP DID NOT RELEASE. THE LOOP WAS STUCK INSIDE THE APPLICATOR. THERE WAS A SURGICAL DELAY OF TWO (2) HOURS WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THIS WAS THE SECOND USE OF THIS PRODUCT. THE USER THAT HANDLED THE DEVICE HAD FAMILIARITY WITH ALL THE PARTICULARITIES OF THE PRODUCT. NO PATIENT INJURY OR INFECTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11596436 ↗MalfunctionFeb 23, 2020Entrapment of Device; Failure to Cut; Ejection Problem; Entrapment of Device; Failure to Cut; Ejection Problem
THE SERVICE CENTER RECEIVED A REPORT OF A LIGATING DEVICE, REUSABLE LOOP, (HX-20U-1), LOT NUMBER 98K, THAT WOULD NOT RELEASE FROM A POLYP AND HAD TO BE SURGICALLY RETRIEVED. THE PHYSICIAN WAS PERFORMING A POLYPECTOMY AND USED TWO LOOPS TO CUT A POLYP WHEN ONE LOOP BECAME STUCK IN A LARGE POLYP. IT WAS REPORTED THE LOOP DEVICE WOULD NOT RELEASE FROM THE ACCESSORY, AND THE PHYSICIAN HAD TO PERFORM SURGERY TO RETRIEVE THE POLYP WITH THE LOOP. IT WAS NOT REPORTED THE LENGTH OF TIME THE PATIENT WAS UNDER GENERAL ANESTHESIA BUT IT WAS REPORTED THERE WAS NO BLOOD LOSS. IT WAS REPORTED THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS STABLE.
Patient problems: Tissue Damage
MAUDE report 9742916 ↗
Other Ligator, esophageal devices
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- Saeed G22692Cook Incorporated · Ligator, esophageal295 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal1 recall239 reports
- Saeed G22553Cook Incorporated · Ligator, esophageal289 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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