BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 5724663 · Received June 14, 2016

    Report

    Report Number
    3005099803-2016-01691
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    May 21, 2016
    Report Date
    May 23, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: RECEIVED ONE SPEEDBAND SUPERVIEW SUPER 7 DEVICE FOR ANALYSIS WITH RESIDUE PRESENT INDICATING USE. NO LABELS OR PACKAGING WERE RETURNED, HOWEVER, UPN (B)(4) LOT 19088656 WERE WRITTEN ON THE RETURNED RGA FORM. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE TRIP WIRE TO BE BENT AND INSERTED INTO THE IRRIGATION TUBE. ALL SEVEN BANDS REMAINED ON THE LIGATOR HEAD WITH THE FIRST FIVE BANDS MOVED OUT OF POSITION. THE LIGATOR TEETH WERE DAMAGED AND THE SUTURE WAS BROKEN WITH PORTIONS ATTACHED TO BOTH THE LIGATOR HEAD AND TRIP WIRE LOOP. THE TRIP WIRE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE POST AND THE CRIMP WAS CAUGHT INSIDE THE POST. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE SLOT. THE SLOT PRESENTED A SLIGHT EVIDENCE OF A PREVIOUS ATTEMPT TO SECURE THE TRIP WIRE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180 DEGREES AND AN AUDIBLE CLICK WAS HEARD. NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE EVALUATION OF THE RETURNED DEVICE, IT IS POSSIBLE THE TRIP WIRE WAS NOT TIGHTENED APPROPRIATELY OR THE WIRE WAS NOT WOUND PROPERLY AROUND THE SPOOL, WHICH WOULD CAUSE THE SYSTEM TIMING TO BE INCORRECT ULTIMATELY IMPACTING THE DEPLOYMENT ACTIVITY OF THE BANDS, HOWEVER, IT CANNOT BE CONFIRMED THAT THE TRIP WIRE WAS NOT SECURED PROPERLY DURING USE. GIVEN THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. A SHIP HISTORY REVIEW WAS PERFORMED AND FOUND LOT 19088656 WAS THE ONLY LOT OF SPEEDBAND SUPERVIEW SUPER 7 BOX 1 (B)(4) SHIPPED TO THIS CUSTOMER. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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) WITH BANDING PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE "BAND CAME APART" AND THE BANDS COULD NOT BE DEPLOYED. 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. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, 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) WITH BANDING PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE "BAND CAME APART" AND THE BANDS COULD NOT BE DEPLOYED. 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. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378940 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542250 19088656

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention