BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5691213 · Received June 1, 2016

    Report

    Report Number
    3005099803-2016-01449
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS RETURNED FOR ANALYSIS WITH RESIDUE PRESENT INDICATING USE. A VISUAL EXAMINATION OF THE LIGATOR HEAD FOUND TWO BANDS REMAINING AND MOVED OUT OF POSITION; ONLY ONE DEPLOYED BAND WAS RETURNED. THERE WAS NO ISSUE WITH THE IRRIGATION TUBE. THE SUTURE WAS INTACT AND ATTACHED TO THE TRIP WIRE LOOP. IT WAS NOTICED THAT THE LIGATOR TEETH WERE DAMAGED. THE ADAPTER RING WAS WITHOUT ANY DEFECT AND WAS PROPERLY ATTACHED. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT. THE PROXIMAL LOOP WAS RETRACTED INTO THE POST AND THE CRIMP WAS CAUGHT INSIDE THE SLOT. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB TO 2 FULL ROTATIONS. AN AUDIBLE CLICK WAS HEARD AND INDENTS WERE FELT FOR EACH 180 DEGREE OF ROTATION. NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT APPEARS THAT THE TRIP WIRE WAS NOT PROPERLY TIGHTENED AND SECURED DURING DEVICE SET-UP, AS INSTRUCTED IN THE DFU. FAILURE TO PROPERLY TIGHTEN AND SECURE THE TRIP WIRE WERE MOST LIKELY IMPACTED THE TIMING OF BAND DEPLOYMENT AND CONTRIBUTED TO THE EVENT. THEREFORE, THE MOST PROBABLY ROOT CAUSE IS USER/USE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO BANDS DEPLOYED WHEN THE PHYSICIAN DEPLOYED THE BANDS. ON THE SECOND ATTEMPT, THREE BANDS DEPLOYED. NO AUDIBLE CLICK WAS HEARD WHEN THE HANDLE KNOB WAS TURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO BANDS DEPLOYED WHEN THE PHYSICIAN DEPLOYED THE BANDS. ON THE SECOND ATTEMPT, THREE BANDS DEPLOYED. NO AUDIBLE CLICK WAS HEARD WHEN THE HANDLE KNOB WAS TURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346316 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 18875289

    Patients

    Seq Age Sex Outcome Treatment
    1