BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2974647 · Received January 30, 2013

    Report

    Report Number
    1037905-2013-00047
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE OF THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FROM THE REPORTED OBSERVATION COULD NOT BE DETERMINED. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE ENDOSCOPE ACCESSORY CHANNEL IS COMPROMISED. IN THESE CASES, THE ENDOSCOPE ACCESSORY CHANNEL COLLAPSES, RESTRICTING THE TRIGGER CORD AND PREVENTING PROPER BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING STATEMENT: "THE USE OF AN ENDOSCOPE IN A SOUND STATE OR REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE." ANOTHER POSSIBLE CONTRIBUTING FACTOR TO BAND DEPLOYMENT DIFFICULTY INCLUDES ALLOWING THE TRIGGER CORD TO BECOME LODGED BETWEEN THE BARREL AND THE DISTAL END OF THE ENDOSCOPE. THIS CAN RESTRICT TRIGGER CORD MOVEMENT AND RESULT IN BAND DEPLOYMENT DIFFICULTY. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE TRIGGER CORD IS NOT PROPERLY SEATED IN THE HANDLE ASSEMBLY. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT THE KNOT MUST BE SEATED INTO THE HOLE OR THE HANDLE WILL NOT FUNCTION PROPERLY. THE INSTRUCTIONS FOR USE DIRECT THE USER TO REPLACE THE HANDLE IN THE TWO-WAY POSITION AND LOOSEN THE TRIGGER CORD SLIGHTLY IF THE BAND WILL NOT DEPLOY. THE USER IS THEN INSTRUCTED TO RETURN THE HANDLE TO THE FIRING POSITION AND CONTINUE WITH DEPLOYMENT OF THE BAND(S). SLIPPAGE OF THE BAND FROM THE VARIX CAN OCCUR IF THE ENDOSCOPE IS ADVANCED BEYOND THE BANDED SITE. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT PASSING THE ENDOSCOPE OVER A PREVIOUSLY PLACED BAND MAY DISLODGE THE BAND. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE ENDOSCOPE TIP IN A STRAIGHT POSITION DURING THE LOADING PROCESS. LOADING THE BARREL AND TRIGGER CORD WITH THE ENDOSCOPE TIP CURVED CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. PREMATURE BAND DEPLOYMENT CAN OCCUR IF CARE IS NOT EXERCISED WHILE LOADING THE DEVICE ON THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO SLOWLY ROTATE THE HANDLE CLOCKWISE TO WIND THE TRIGGER CORD ONTO THE HANDLE SPOOL UNTIL IT IS TAUT. THE INSTRUCTIONS ADVISE THE USER THAT CARE MUST BE TAKEN TO AVOID PREMATURE BAND DEPLOYMENT WHEN WINDING THE TRIGGER DURING SYSTEM PREPARATION. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS PLACED IN THE FIRING POSITION BEFORE THE ENDOSCOPE IS IN PLACE INSIDE THE PATIENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO KEEP THE HANDLE IN THE TWO-WAY POSITION PRIOR TO INTRODUCING THE ENDOSCOPE. AFTER INCUBATION, THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE FIRING POSITION. RAPID ROTATION OF THE LIGATOR HANDLE CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO MAINTAIN SUCTION AND DEPLOY THE BAND BY ROTATING THE HANDLE CLOCKWISE UNTIL BAND RELEASE IS FELT. DURING THE PROCEDURE, ENDOSCOPIC SUCTION IS APPLIED TO THE BANDING SITE TO PROPERLY PLACE A LIGATOR BAND. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS ROTATED BEFORE MAINTAINING SUCTION ON THE BANDING SITE. THE INSTRUCTIONS FOR USE ADVISE THE USER TO MAINTAIN SUCTION WHILE DEPLOYING THE BAND. IF THE LIGATOR HANDLE IS IN THE FIRING POSITION WHILE THE ENDOSCOPE IS STRAIGHTENED, THIS CAN RESULT IN PREMATURE BAND DEPLOYMENT DUE TO EXTENSION ON THE TRIGGER CORD. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION BEFORE STRAIGHTENING THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO REMOVE THE ENDOSCOPE AND ATTACH A NEW LIGATOR IF MORE BANDS ARE REQUIRED. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WIL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED IN WHAT WAS REPORTED TO BE THE ESOPHAGUS OR STOMACH. EVERYTHING PASSED WITH NO PROBLEM. THEY WENT TO FIRE THE FIRST BAND AND DIDN'T FEEL ANYTHING. THE DOCTOR PULLED THE SCOPE AWAY TO SEE THE 3 BANDS HAD FIRED TOGETHER. THE REMAINING BANDS ON THIS DEVICE WERE ABLE TO BE USED FOR COMPLETION OF THE PROCEDURE. THE ONLY SECTIONS OF THE DEVICE THAT REMAINED INSIDE THE PATIENT'S BODY ARE THE BANDS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41615 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3210681

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR OLYMPUS ENDOSCOPE G1S OR GIS 160