BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4791329 · Received May 22, 2015

    Report

    Report Number
    3005099803-2015-01432
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    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 DEVICE FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THERE WAS NO ISSUE NOTED WITH THE EXTENSION TUBE. PHYSICAL EXAMINATIONS OF THE LIGATOR HEAD FOUND ALL SEVEN BANDS PRESENT AND WERE MOVED OUT OF POSITION. THE LIGATOR TEETH WERE DAMAGED. THE SUTURE WAS INTACT AND ATTACHED TO THE TRIP WIRE LOOP. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT, WITH THE PROXIMAL LOOP RETRACTED INTO THE HANDLE POST. THE TRIP WIRE CRIMP WAS CAUGHT INSIDE THE HANDLE POST. THERE WAS NO EVIDENCE PRESENT THAT THE TRIP WIRE HAD BEEN SECURED. FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180 DEGREES; NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BANDS FAILED TO DEPLOY COULD NOT BE FUNCTIONALLY VERIFIED; HOWEVER, VISUAL EVALUATION INDICATE THAT THE DEVICE MOST LIKELY FAILED TO DEPLOY THE BANDS DURING THE PROCEDURE. IT DOES NOT APPEAR THAT THE TRIP WIRE WAS CINCHED IN THE HANDLE SLOT AS INSTRUCTED IN THE DFU, WHICH IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY. 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) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WOULD NOT DEPLOY. 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
    335163 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 17797305

    Patients

    Seq Age Sex Outcome Treatment
    1