BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 23072925 · Received September 17, 2025

    Report

    Report Number
    3005099803-2025-04784
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF SUTURE STUCK IN HOUSING.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H2 (CORRECTION): BLOCK H6 (DEVICE CODES) HAS BEEN UPDATED BASED ON THE INFORMATION THAT WAS IDENTIFIED ON DECEMBER 8, 2025. BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF SUTURE STUCK IN HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN AN UNKNOWN PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. IT WAS REPORTED THAT THE THREAD WHICH TRIGGERED THE RELEASE OF THE LIGATURES WAS LOCATED IN THE MIDDLE OF THE DEVICE, OBSTRUCTING THE OPERATOR'S VIEW. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN AN UNKNOWN PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. IT WAS REPORTED THAT THE THREAD WHICH TRIGGERED THE RELEASE OF THE LIGATURES WAS LOCATED IN THE MIDDLE OF THE DEVICE, OBSTRUCTING THE OPERATOR'S VIEW. IT WAS NOTED THAT THE THREAD WAS MORE FRAGILE THAN USUAL. UPON REMOVAL OF THE ENDOSCOPE AND THE DEVICE, THE SUTURE WAS REPORTEDLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. 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
    1635366 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0035488371 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown