BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3023645 · Received March 27, 2013

    Report

    Report Number
    3005099803-2013-01843
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE LIGATOR HEAD FOUND ALL SEVEN BANDS PRESENT WITH ONE BAND BROKEN AND CAUGHT UNDER THREE OTHER BANDS. THE TEETH OF THE LIGATOR HEAD WAS DAMAGED AND THE SUTURE WAS BROKEN. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY, HOWEVER, THE HANDLE ASSEMBLY SLOT PRESENTED EVIDENCE THAT THE TRIP WIRE WAS SECURED AT SOME POINT PRIOR TO RECEIPT OF THE DEVICE. A FUNCTIONAL ANALYSIS REVEALED THAT THE WHEN THE HANDLE KNOB WAS ROTATED 180 DEGREES, AN AUDIBLE CLICK COULD BE HEARD. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-01842 AND MANUFACTURER REPORT # 3005099803-2013-01843 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR'S WERE USED FOR A VARICEAL BANDING PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO THE TARGET AREA AND THE PHYSICIAN ROTATED THE HANDLE FOR DEPLOYMENT HOWEVER, THE BAND FAILED TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND FROM SERVICE. ANOTHER DEVICE WAS SET UP ON THE SCOPE AND ADVANCED TO THE TARGET AREA AND AGAIN; THE PHYSICIAN ROTATED THE HANDLE FOR DEPLOYMENT HOWEVER, THE BAND FAILED TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND FROM SERVICE AND THE CASE WAS COMPLETED WITH A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-01842 AND MANUFACTURER REPORT # 3005099803-2013-01843 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR¿S WERE USED FOR A VARICEAL BANDING PROCEDURE PERFORMED ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO THE TARGET AREA AND THE PHYSICIAN ROTATED THE HANDLE FOR DEPLOYMENT HOWEVER; THE BAND FAILED TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND FROM SERVICE. ANOTHER DEVICE WAS SET UP ON THE SCOPE AND ADVANCED TO THE TARGET AREA AND AGAIN; THE PHYSICIAN ROTATED THE HANDLE FOR DEPLOYMENT HOWEVER; THE BAND FAILED TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND FROM SERVICE AND THE CASE WAS COMPLETED WITH A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126763 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 15203982

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR