Clip HX-610-090 (REF N6012330)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
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 04953170415111), received between Nov 15, 2021 and Nov 15, 2021 — 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
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE USER FACILITY AS FOLLOWS, PATIENT WAS SUSPECTED OF HAVING ULCERATIVE COLITIS, A COLON EXAMINATION WAS PERFORMED ON (B)(6) 2021. A POLYP WAS FOUND, AND AFTER ENDOSCOPIC MUCOSAL RESECTION(EMR), A HEMOSTATIC CLIP (SUBJECT DEVICE) WAS USED. TWO DAYS AFTER THE PROCEDURE, SYMPTOMS OF ITCHING AND BLISTERS DEVELOPED IN THE MOUTH AND ANUS OF PATIENT. TOPICAL STEROIDS WERE APPLIED TO THE MOUTH, AND THE SYMPTOMS ARE NOW RECOVERING. HOWEVER, BLISTERS-LIKE SYMPTOMS ALSO APPEAR ON THE FINGERTIPS. THE PATIENT ALSO HAS A HISTORY OF METAL ALLERGIES. THE DEGREE OF ALLERGY IS UNKNOWN BECAUSE NO ALLERGY TEST HAS BEEN PERFORMED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 12809604 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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