BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 20552511 · Received October 28, 2024

    Report

    Report Number
    3005099803-2024-05397
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201953
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: (PRO CODE (PRODUCT CODE)) FHN BLOCK H6: 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 A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE KIT HAD THE LIGATURE CONTAINMENT MECHANISM IN AN ERRATIC POSITIONING, PREVENTING THE BANDS FROM BEING FIRED. THERE WERE NO PATIENT COMPLICATIONS 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
    978669 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, HEMORRHOIDAL MND BOSTON SCIENTIFIC CORPORATION M00542250 0033734565 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female