BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 22011312 · Received May 13, 2025

    Report

    Report Number
    3005099803-2025-02179
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY IMDRF CODE A150103 CAPTURES THE REPORTABLE EVENT OF PREMATURE DEPLOYMENT D2B ADDITIONAL PRODUCT CODE FHN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICES LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THERE IS NO SOUND WHEN THE HANDLE UNIT ROTATES, CAUSING THREE RUBBER BANDS TO BE FIRED FROM THE SAME POSITION. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356856 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0035268305 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown