BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4242781 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03637
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. REPORTED ISSUE OF BANDS MISFIRED. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS PREMATURELY DEPLOYED. THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GIVEN THE EVENT DESCRIPTION, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2014-03636 PERTAINS TO THE FIRST SPEEDBAND SUPERVIEW SUPER 7 DEVICE AND MANUFACTURER REPORT #3005099803-2014-03637 PERTAINS TO THE SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 DEVICES WERE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ROTATED THE HANDLE TO DEPLOY THE BANDS OF THE FIRST DEVICE THEY WOULD EITHER DEPLOY IN ADVANCE OR DEPLOY LATE. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED USING A THIRD SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014. THE COMPLAINANT CLARIFIED THAT THE BANDS PREMATURELY DEPLOYED. REPORTEDLY, THE BANDS DID NOT DEPLOY ON THE CLICK.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2014-03636 PERTAINS TO THE FIRST SPEEDBAND SUPERVIEW SUPER 7 DEVICE AND MANUFACTURER REPORT #3005099803-2014-03637 PERTAINS TO THE SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 DEVICES WERE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ROTATED THE HANDLE TO DEPLOY THE BANDS OF THE FIRST DEVICE THEY WOULD EITHER DEPLOY IN ADVANCE OR DEPLOY LATE. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED USING A THIRD SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725560 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250

    Patients

    Seq Age Sex Outcome Treatment
    1