BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 23293257 · Received October 15, 2025

    Report

    Report Number
    3005099803-2025-05368
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING AN OESOPHAGOGASTRODUODENOSCOPY (OGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BANDS DID NOT DEPLOY WHEN THE HANDLE WAS TURNED. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357289 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0036598806 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown