BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2894566 · Received January 3, 2013

    Report

    Report Number
    3005099803-2012-06407
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE HANDLE ASSEMBLY, TRIPWIRE, SUTURE, AND LIGATOR HEAD WERE RETURNED FOR EVALUATION. THERE WAS RESIDUE PRESENT ON THE DEVICE WHICH IS INDICATIVE OF USE. THE EVALUATION REVEALED THAT ALL SEVEN BANDS WERE PRESENT AND IN PROPER POSITION. ADDITIONALLY, THE SUTURE LOOP WAS INTACT AND THE SUTURE LOOP HAD NOT BEEN ATTACHED TO THE TRIP WIRE LOOP. THE TRIP WIRE WAS FOUND TO BE WOUND LOOSELY AROUND THE SPOOL. FURTHER ANALYSIS OF THE HANDLE SLOT REVEALED THAT THE TRIPWIRE WAS NOT CINCHED (SECURED) IN THE HANDLE ASSEMBLY SLOT AND THERE WAS NO VISIBLE EVIDENCE TO SUGGEST THAT IT WAS CINCHED DURING USE. ADDITIONALLY THE TRIP WIRE HAD BEEN PULLED OUT OF THE HANDLE ASSEMBLY STEM AND INJECTION SEPTUM. VISUAL EXAMINATION OF THE TRIP WIRE CONFIRMED THAT THE TRIP WIRE WAS NOT BROKEN. A FUNCTIONAL EVALUATION WAS PERFORMED BY TURNING THE HANDLE KNOB 180º AND AN AUDIBLE CLICK WAS HEARD. THE CONDITION OF THE RETURNED INCIDENT DEVICE COULD NOT BE CONFIRMED; AS THE TRIP WIRE WAS NOT BROKEN. HOWEVER; AN EXAMINATION OF THE LIGATOR HEAD FOUND ALL SEVEN BANDS PRESENT AND IN PROPER POSITION AND THE SUTURE LOOP WAS INTACT. THE SUTURE LOOP DID NOT APPEAR TO HAVE BEEN ATTACHED TO THE TRIP WIRE LOOP. THE TRIP WIRE WAS FOUND TO HAVE BEEN PULLED OUT OF THE HANDLE ASSEMBLY STEM AND INJECTION SEPTUM. ADDITIONALLY THE TRIP WIRE HAD NOT BEEN SECURED IN THE HANDLE ASSEMBLY SLOT WHICH ALLOWED THE TRIP WIRE TO BE WOUND LOOSELY AROUND THE HANDLE ASSEMBLY SPOOL. DURING USE, THE HANDLE ASSEMBLY STEM IS TO BE INSERTED INTO THE BIOPSY VALVE ON THE SCOPE WORKING CHANNEL. THE TRIP WIRE NORMALLY EXITS THE HANDLE ASSEMBLY STEM BUT THIS DEVICE WAS ALTERED SUCH THAT THE TRIP WIRE BYPASSED THE INJECTION SEPTUM AND HANDLE ASSEMBLY STEM. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT APPEARS THE CUSTOMER PARTIALLY DISASSEMBLED THE DEVICE. IT WAS ALSO NOTED THAT IF THE TRIP WIRE HAD BEEN PLACED THROUGH THE SCOPE WORKING CHANNEL, ATTACHED TO THE SUTURE LOOP AND THE TRIP WIRE TIGHTENED AND SECURED IN THE HANDLE ASSEMBLY, THEN THE DEVICE COULD NOT HAVE BEEN REMOVED FROM THE SCOPE WITHOUT CUTTING/ BREAKING THE TRIP WIRE OR THE SUTURE. THEREFORE, THE DEVICE COULD NOT HAVE BEEN USED AS PER THE DIRECTION FOR USE (DFU), REMOVED FROM THE SCOPE AND RETURNED IN ITS NOTED CONDITION. BASED ON THE EVALUATION THE ROOT CAUSE COULD NOT BEEN CONFIRMED. 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 FOR AN ESOPHAGEAL VARICES BANDING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE HANDLE WAS TURNED TO DEPLOY A BAND, THE TRIP WIRE "SNAPPED." REPORTEDLY, THE TRIP WIRE BROKE NEAR THE HANDLE; OUTSIDE OF THE PATIENT. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR 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 MULTIPLE BAND LIGATOR WAS USED FOR AN ESOPHAGEAL VARICES BANDING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE HANDLE WAS TURNED TO DEPLOY A BAND, THE TRIP WIRE 'SNAPPED.' REPORTEDLY, THE TRIP WIRE BROKE NEAR THE HANDLE; OUTSIDE OF THE PATIENT. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR 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
    3130 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 15554917

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR