Clip HX-610-135 (REF N1085630)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170200311), received between Jun 22, 2023 and Aug 8, 2024 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
- Retraction 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.
MalfunctionAug 8, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED, THAT THE CLIP GRIPPING THE MUCOSA COULD NOT BE REMOVED. THE ISSUE OCCURRED, DURING AN THERAPEUTIC PROCEDURE. AND THE PROCEDURE WAS COMPLETED USING THE SIMILAR SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945378 ↗InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHEN THEY WERE TRYING TO STOP THE BLEEDING INSIDE THE PATIENT'S BODY, THE CLIP WAS NOT ABLE TO CLIP AND FELL INSIDE THE PATIENT'S BODY. THE FALLEN PART HAS BEEN RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HEALTH RISK TO THE PATIENT. IT WAS LATER REPORTED THREE CLIPS COULD NOT BE CLIPPED AND FELL INTO THE BODY. THE CLAWS WERE ALREADY CLOSED WHEN THEY WERE EJECTED FROM THE ROTATING CLIP DEVICE AND THE CONNECTING ROD CAME OFF THE HOOK AND FELL INTO THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19649046 ↗InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHEN THEY WERE TRYING TO STOP THE BLEEDING INSIDE THE PATIENT'S BODY, THE CLIP WAS NOT ABLE TO CLIP AND FELL INSIDE THE PATIENT'S BODY. THE FALLEN PART HAS BEEN RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HEALTH RISK TO THE PATIENT. IT WAS LATER REPORTED THREE CLIPS COULD NOT BE CLIPPED AND FELL INTO THE BODY. THE CLAWS WERE ALREADY CLOSED WHEN THEY WERE EJECTED FROM THE ROTATING CLIP DEVICE AND THE CONNECTING ROD CAME OFF THE HOOK AND FELL INTO THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19648601 ↗MalfunctionOct 24, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE CLIP DESPITE CONFIRMING THE MUCOUS MEMBRANE WAS FIRMLY GRASPED, DID NOT RELEASE PROPERLY. DESPITE HEARING A CLICKING SOUND, THE CLIP COULD NOT BE RELEASED FROM THE MAIN BODY OF THE CLIP DEVICE. AFTER THAT, THE SHEATH WAS MOVED, AND IT CAME OFF. THE EVENT OCCURRED DURING THE THERAPEUTIC HEMOSTATIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17997929 ↗InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PS-10 EVALUATION OF THE USEFULNESS OF PROPHYLACTIC CLIPPING WITH SURECLIP FOR WOUND BLEEDING AFTER ENDOSCOPIC PAPILLECTOMY". COMPLICATIONS INCLUDING POSTOPERATIVE WOUND BLEEDING ARE FREQUENTLY OBSERVED IN ENDOSCOPIC PAPILLECTOMY (EP). WE HAVE LONG USED A CLIP TO SUTURE THE WOUND TO PREVENT WOUND BLEEDING. RECENTLY, WE HAVE BEEN USING THE SURE CLIP (MICRO-TECH), WHICH IS EASY TO OPERATE EVEN WITH A DUODENOSCOPE. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF SURE CLIP PLACEMENT FOR POST-EP WOUND BLEEDING. TYPE OF ADVERSE EVENT/NUMBER OF PATIENTS: BLEEDING - 39.2%; PANCREATITIS - 8.7%; CHOLANGITIS - 0.5%; PERFORATION - 3.3%.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17188024 ↗
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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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