BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 3222111 · Received July 2, 2013

    Report

    Report Number
    1037905-2013-00500
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE LOADING CATHETER WAS RETURNED WITH ONE HOOK MISSING AND ONE HOOK REMAINING ATTACHED AND FULLY SEATED. A TENSILE TEST WAS PERFORMED ON THE REMAINING HOOK AND WAS FOUND TO BE WITHIN SPECIFICATION. A PIN GAUGE WAS USED TO MEASURE THE INNER DIAMETER OF THE CATHETER AND WAS FOUND TO BE WITHIN SPECIFICATION. NO DEFECTS OR NONCONFORMITY WERE FOUND IN THE RETURNED DEVICE. THE LENGTH OF THE LOADING CATHETER WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS A SLIGHT BEND IN THE CATHETER APPROXIMATELY 1CM FROM THE HOOK THAT REMAINED ON THE CATHETER. MOVEMENT OF THE HANDLE WHEEL WAS PERFORMED AND FUNCTIONED AS INTENDED. THE TRIGGER CORD WAS DISMANTLED FROM THE MBL ASSEMBLY TO FULLY INVESTIGATE THE INTEGRITY OF THE TRIGGER CORD ASSEMBLY. THE CORD WAS EXAMINED USING MAGNIFICATION AND FOUND TO BE MFG CORRECTLY. THE STRING LENGTH WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. A PRODUCT SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. A 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 THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUT LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTION FOR USE DIRECT THE USER TO ATTACH THE HOOK ON THE END OF THE LOADING CATHETER, LEAVING APPROXIMATELY 2 CM OF TRIGGER CORD BETWEEN THE KNOT AND THE HOOK. IF THE KNOT AND THE HOOK ARE PLACED CLOSER THAN 2CM, THIS CAN CREATE RESISTANCE WHEN WITHDRAWING THE LOADING CATHETER THROUGH THE LIGATOR HANDLE AND/OR ACCESSORY CHANNEL OF THE ENDOSCOPE. IF ADD'L PRESSURE IS APPLIED TO THE LOADING CATHETER WHEN RESISTANCE IS ENCOUNTERED, THIS COULD CONTRIBUTE TO SEPARATION OF THE BLUE HOOK FROM THE LOADING CATHETER. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTION TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG 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

    IN PREPARATION FOR A LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. DURING THE LOADING PROCESS THE BLUE HOOK WAS INSERTED INT THE BANDING DEVICE. THE BLUE HOOK BROKE OFF INTO THE ENDOSCOPE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COOK DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. 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
    301475 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3271222

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR OLYMPUS ENDOSCOPE GIF 160