BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3162683 · Received June 11, 2013

    Report

    Report Number
    3005099803-2013-04894
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONLY THE HANDLE OF THE DEVICE WAS RETURNED; THE LIGATOR HEAD AND BANDS WERE NOT RETURNED. VISUAL EXAMINATION FOUND THE TRIP WIRE PROPERLY CINCHED INTO THE HANDLE SLOT. NO DEFECTS, OR DAMAGE, WAS FOUND WITH THE HANDLE. FAILURE TO TIGHTEN THE TRIP WIRE COULD ULTIMATELY IMPACT THE DEPLOYMENT ACTIVITY OF THE BANDS. IT CANNOT BE CONFIRMED THAT THE TRIP WIRE WAS NOT SECURED PROPERLY DURING USE; THEREFORE, THE MOST PROBABLE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS MISFIRING. TWO BANDS WERE COMING OFF AT ONE TIME SO THEY WOULD NOT STAY ON THE TISSUE. THE BANDS ARE LEFT INSIDE OF THE PATIENT. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION 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 DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS MISFIRING. TWO BANDS WERE COMING OFF AT ONE TIME SO THEY WOULD NOT STAY ON THE TISSUE. THE BANDS ARE LEFT INSIDE OF THE PATIENT. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262741 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 15986477

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR