BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER MULTI-BAND LIGATOR

    MDR report key: 3943519 · Received April 30, 2014

    Report

    Report Number
    1037905-2014-00157
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. THE HANDLE, LOADING CATHETER, BARREL, AND TRIGGER CORD WERE INCLUDED IN THE RETURN BUT THE BLACK AND AMBER BANDS WERE NOT RETURNED. AN EVALUATION OF THE HANDLE WHEEL MOVEMENT WAS PERFORMED AND THE WHEEL FUNCTIONED AS INTENDED. THE TRIGGER CORD WAS EXAMINED AND A KNOT WAS PRESENT IN THE TWO LEGS OF THE STRING MIDWAY BETWEEN THE END OF THE BRAIDED SECTION OF THE CORD AND THE NEAREST MOLDED BEAD. ALL OF THE DEPLOYMENT BEADS WERE PRESENT. ONCE THE KNOT WAS REMOVED, THE BEADS WERE VERIFIED FOR CORRECT LOCATION. THE BEADS APPEAR TO BE ON THE SHORT END OF THE TOLERANCE BUT THIS IS DUE TO THE SIGNIFICANT KINKS IN THE STRING THAT RESULTED FROM THE KNOT. THE BEADS WERE EXAMINED USING MAGNIFICATION AND FOUND TO BE MANUFACTURED CORRECTLY. THE LENGTH OF THE TRIGGER CORD WAS MEASURED AND WAS WITHIN SPECIFICATION. THE TRIGGER CORD WAS INTACT AND NOT BROKEN. THE BARREL WAS VISUALLY INSPECTED AND NO DEFECTS THAT MIGHT LEAD TO PREMATURE BAND DEPLOYMENT WERE FOUND. A PRODUCT SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. TWO UNUSED PRODUCTS FROM THE LOT NUMBER PROVIDED IN THE REPORT WERE ALSO RETURNED FOR EVALUATION. DURING THE LABORATORY EVALUATION, THE BARRELS CONTAINING THE BANDS WERE VISUALLY EXAMINED. NO DEFECTS OR ABNORMALITIES WERE OBSERVED WITH THE BANDS, BARREL OR TRIGGER CORDS. THE DEVICES WERE ATTACHED TO AN OLYMPUS 2.8 CHANNEL GIF Q20 ENDOSCOPE. ALL BANDS FIRED SUCCESSFULLY AND INDEPENDENTLY. THEREFORE THE DEVICES FUNCTIONED AS INTENDED. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE ALL OF THE DEVICE COMPONENTS OF THE USED DEVICE WERE NOT RETURNED. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE (USING THE RETURNED SEALED DEVICES) DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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 WH!LE 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 TENSION ON THE TRIGGER CORD. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION BEFORE STRAIGHTENING THE ENDOSCOPE. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO PREMATURE BAND DEPLOYMENT 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 PREMATURE BAND DEPLOYMENT IF ENOUGH TENSION IS APPLIED TO PULL THE CORD FREE. 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 WILL 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 A PROCEDURE, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED TO BAND ESOPHAGEAL VARICES. THE NURSES PREPARED THE SET. JUST AT THE PHYSICIAN SUCKED THE VARIX AND TURNED THE SPOOL TO LIGATE, THE STRING [TRIGGER CORD] SNAPPED. ALL THE BANDS DROPPED INTO THE PT'S STOMACH. THE PHYSICIAN RETRIEVED ALL THE BANDS WITH GRASPING FORCEPS. ANOTHER SET WAS USED TO FINISH THE PROCEDURE. THE DETACHED BANDS WERE RETRIEVED FROM THE PT'S STOMACH WITH GRASPING FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258713 6 SHOOTER MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3390110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention OLYMPUS GIF-260 ENDOSCOPE