BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 24747050 · Received March 31, 2026

    Report

    Report Number
    9614641-2026-00340
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    October 8, 2025
    Report Date
    March 31, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    MND
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1/INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ISCHEMIC POLYPECTOMY FOR SMALL-BOWEL POLYPS IN PEDIATRIC PEUTZ-JEGHERS SYNDROME." BACKGROUND AND AIMS: PEUTZ-JEGHERS SYNDROME (PJS) IS CHARACTERIZED BY THE DEVELOPMENT OF HAMARTOMATOUS POLYPS IN THE GASTROINTESTINAL TRACT THAT CAN CAUSE CHRONIC BLOOD LOSS. ISCHEMIC POLYPECTOMY HAS EMERGED AS A LOW-RISK TECHNIQUE IN ADULT PATIENTS WITH PJS BUT REMAINS LARGELY UNDOCUMENTED IN PEDIATRIC POPULATIONS. THIS VIDEO PRESENTS THE FIRST PUBLISHED CASE DEMONSTRATING ISCHEMIC POLYPECTOMY IN A PEDIATRIC PATIENT, TO OUR KNOWLEDGE. METHODS: A 12-YEAR-OLD GIRL WITH PJS AND CHRONIC ANEMIA UNDERWENT BALLOON-ASSISTED ENTEROSCOPY. SEVEN PEDUNCULATED SMALL-BOWEL POLYPS WERE IDENTIFIED AND TREATED USING ISCHEMIC POLYPECTOMY WITH A DETACHABLE SNARE. RESULTS: THREE REPRESENTATIVE POLYPECTOMIES ARE SHOWN. THE SNARE WAS TIGHTENED AT THE POLYP STALK UNTIL ISCHEMIC CHANGES OCCURRED, THEN CINCHED AND DEPLOYED. ONE INSTANCE REQUIRED A SECOND SNARE BECAUSE OF EQUIPMENT MALFUNCTION. ALL POLYPS WERE SUCCESSFULLY TREATED WITHOUT ELECTROCAUTERY, BLEEDING, OR PERFORATION. FOLLOW-UP DEMONSTRATED IMPROVEMENT IN LONGSTANDING ANEMIA, WITH A RISE IN HEMOGLOBIN FROM 9.1 TO 12.4 G/DL AT 6 WEEKS, SUPPORTING THERAPEUTIC BENEFIT. REPEAT CAPSULE ENDOSCOPY WAS PLANNED. CONCLUSIONS: ISCHEMIC POLYPECTOMY USING BALLOON-ASSISTED ENTEROSCOPY IS FEASIBLE, EFFECTIVE, AND SAFE IN PEDIATRIC PJS. BY AVOIDING THERMAL ENERGY, IT MAY REDUCE THE RISK OF TRANSMURAL INJURY AND REPRESENTS A VALUABLE OPTION FOR CHILDREN WITH NUMEROUS PEDUNCULATED SMALL-BOWEL POLYPS. TYPE OF EVENT: THE LITERATURE DESCRIBED A DEVICE MALFUNCTION OF THE SINGLE USE LIGATING DEVICE. AFTER ISOLATION OF EACH POLYP, THE DETACHABLE SNARE WAS CAREFULLY POSITIONED AT THE BASE OF THE STALK AND SLOWLY TIGHTENED UNTIL A DUSKY PURPLE COLOR CHANGE INDICATED VASCULAR COMPROMISE. THE SNARE WAS THEN CINCHED AND DEPLOYED, ALLOWING THE POLYP TO REMAIN IN SITU FOR AUTOAMPUTATION. IN ONE CASE, THE DETACHABLE SNARE FAILED TO DEPLOY PROPERLY DESPITE INITIAL COLOR CHANGE, RESULTING IN REPERFUSION OF THE POLYP. THE VIDEO PROVIDED IN THE ARTICLE FURTHER STATES THAT DESPITE CORRECT POSITIONING INTENTION, THE CINCHED MECHANISM FAILED TO DEPLOY DUE TO A TECHNICAL MALFUNCTION. A SECOND DETACHABLE SNARE WAS PLACED ON THE SAME STALK, LEADING TO SUCCESSFUL ISCHEMIA AND SECURE DEPLOYMENT. THERE WERE NO REPORTS OF PATIENT HARM DUE TO THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800925 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE MND AOMORI OLYMPUS CO., LTD. HX-400U-30 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female SIF-Q180 EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE