Short Clip HX-610-090S (REF N6012530)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 04953170415135), received between Mar 14, 2022 and Mar 14, 2022 — 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
- Chest Pain1
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOSCOPIC HAND SUTURING FOR MUCOSAL DEFECT CLOSURE AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION MAY REDUCE THE RISK OF POSTOPERATIVE BLEEDING IN PATIENTS RECEIVING ANTITHROMBOTIC THERAPY¿, PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE KD-650L USED IN THE ESD PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE FD-411QR USED IN THE ESD PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE FG-21L-1 USED IN THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE HX-610-090S USED DURING THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE GIF-2TQ260M USED DURING THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE THROUGH THE SCOPE NEEDLE HOLDER USED DURING THE EHS PROCEDURES. STUDY AIM: ENDOSCOPIC HAND SUTURING (EHS) IS EXPECTED TO DECREASE THE RISK OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BLEEDING BY CLOSING MUCOSAL DEFECTS. THE STUDY INVESTIGATED THE EFFICACY OF EHS AFTER GASTRIC ESD IN PATIENTS WITH ANTITHROMBOTIC AGENTS. STUDY METHOD: PROSPECTIVE SINGLE-ARM TRIAL, PAT
Patient problems: Chest Pain; Myocardial Infarction
MAUDE report 13763348 ↗
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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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