BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1962081 · Received January 17, 2011

    Report

    Report Number
    3005099803-2011-00074
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE LIGATOR HEAD TO HAVE 5 BLUE BANDS ON IT. THE BANDS HAD BEEN ROLLED AND THE 3RD BAND APPEARS TO HAVE BEEN CUT. THE SUTURE ON THE LIGATOR HEAD WAS FOUND TO BE INTACT AND WITHOUT ISSUE. THE LIGATOR TEETH WERE BENT AND DEFORMED. THE TRIP WIRE WAS WRAPPED AROUND THE HANDLE SPOOL BUT WAS NOT CINCHED IN THE HANDLE ASSEMBLY. THERE WAS NO EVIDENCE THE TRIP WIRE HAD BEEN CINCHED IN THE HANDLE ASSEMBLY DURING USE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB 180º AND AN AUDIBLE CLICK WAS HEARD. NO ISSUE WAS FOUND WITH THE HANDLE ASSEMBLY. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USER ERROR, AS THERE WAS NO VISIBLE EVIDENCE THAT THE TRIPWIRE WAS CINCHED INTO THE HANDLE SLOT. IN ADDITION, DAMAGE TO THE LIGATOR TEETH WAS OBSERVED. THIS IS MOST LIKELY DUE TO OPERATION CONTEXT DURING ATTEMPTS TO DEPLOY THE BANDS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL BAND LIGATION PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY WERE ABLE TO SUCCESSFULLY DEPLOY THE FIRST FIVE BANDS HOWEVER; THE HANDLE WOULD NOT ROTATE WHEN THEY MADE AN ATTEMPT TO DEPLOY THE SIXTH BAND. THE CASE WAS COMPLETED WITH ANOTHER 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL BAND LIGATION PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY WERE ABLE TO SUCCESSFULLY DEPLOY THE FIRST FIVE BANDS HOWEVER; THE HANDLE WOULD NOT ROTATE WHEN THEY MADE AN ATTEMPT TO DEPLOY THE SIXTH BAND. THE CASE WAS COMPLETED WITH ANOTHER 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 13505468

    Patients

    Seq Age Sex Outcome Treatment
    1