Long Clip HX-610-135L (REF N6012830)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
All models of Long Clip (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170415166), received between Jul 25, 2022 and May 14, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 Component4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022244 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022236 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022226 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022225 ↗InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "SECOND-LOOK ENDOSCOPY (SLE) FINDINGS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL EPITHELIAL NEOPLASMS." LITERATURE SUMMARY: THIS STUDY AIMED TO INVESTIGATE SLE FINDINGS AND THEIR ROLE IN PREVENTING DELAYED BLEEDING AFTER COLORECTAL ESD. AMONG THE 375 CASES INVESTIGATED, SLES WERE PERFORMED IN 171 (45.6%) PATIENTS. THE INCIDENCES OF HIGH-RISK ULCER STIGMA AND LOW-RISK STIGMA WERE 5.3% (9/171) AND 94.7% (162/171), RESPECTIVELY. DURING SLE, ENDOSCOPIC HEMOSTASIS WAS PERFORMED MORE FREQUENTLY IN THE HIGH-RISK ULCER STIGMA GROUP THAN IN THE LOW RISK ULCER STIGMA GROUP, BUT MOST OF THE ENDOSCOPIC HEMOSTASIS IN THE HIGH-RISK ULCER STIGMA GROUP (3/4, 75.0%) WERE PROPHYLACTIC HEMOSTASIS. POST-ESD DELAYED BLEEDING OCCURRED IN THREE (0.8%) PATIENTS BELONGING TO THE SLE GROUP, OF WHICH, ONE PATIENT WAS FROM THE HIGH-RISK STIGMA GROUP AND TWO WERE FROM THE LOW-RISK STIGMA GROUP. THE INCIDENCE OF HIGH-RISK ULCER STIGMA DURING SLE WAS LOW, AND DELAYED BLEEDING OCCURRED IN, BOTH, HIGH-RISK AND LOW-RISK GROUPS OF SLE. SLES PERFORMED AFTER COLORECTAL ESD MAY NOT BE EFFECTIVE IN PREVENTING DELAYED BLEEDING, AND FURTHER PROSPECTIVE STUDIES ARE NEED
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15099342 ↗
Other Hemostatic metal clip for the GI tract devices
- Resolution 360 Clip M00521230Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths2,291 reports
- Resolution Clip M00522610Boston Scientific Corporation · Hemostatic metal clip for the GI tract1,116 reports
- Instinct G58010Cook Incorporated · Hemostatic metal clip for the GI tract1 recall1,017 reports
- Resolution 360™ ULTRA Clip M00521400Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths496 reports
- Instinct G18343Cook Incorporated · Hemostatic metal clip for the GI tract244 reports
- MANTIS™ Clip M00521420Boston Scientific Corporation · Hemostatic metal clip for the GI tract195 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract1 recall118 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page