BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULT-BAND LIGATOR

    MDR report key: 4862257 · Received June 17, 2015

    Report

    Report Number
    1037905-2015-00240
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 20, 2015
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THE TRIGGER CORD WAS FOUND TO BE BROKEN. THE BARREL, TRIGGER CORD, AND HANDLE WHEEL WERE RETURNED. THE BREAKAGE WAS LOCATED ON THE LEGS OF THE STRING APPROXIMATELY 9 CM FROM THE DISTAL TRIGGER CORD KNOT NEAR THE BARREL OF THE DEVICE. THE LENGTH OF THE TRIGGER CORD WAS MEASURED TO BE WITHIN SPECIFICATION. AN EVALUATION OF THE HANDLE WHEEL MOVEMENT WAS PERFORMED AND THE WHEEL FUNCTIONED AS INTENDED. THE BARREL WAS RETURNED WITH THE BEADS AND STRING STILL ATTACHED TO IT. THE BARREL HAD ALL 6 BANDS ATTACHED. THE LOADING CATHETER AND IRRIGATION PORT WERE NOT RETURNED WITH THE DEVICE. PER THE LABELING, THE MBL-6 IS COMPATIBLE WITH 9.5-11.5 MM ENDOSCOPE DIAMETERS. THE USER INDICATED THAT THIS PRODUCT WAS USED WITH AN OLYMPUS GIF-H180 ENDOSCOPE WHICH HAS A INSERTION TUBE DIAMETER OF 9.8 MM WHICH IS COMPATIBLE WITH THIS PRODUCT. THE SUBASSEMBLY DEVICE RECORD FOR THE STRING WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED 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 PATIENT ANATOMY OR PROGRESSION OF DISEASE STE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IF EXTREME PRESSURE WAS APPLIED TO HANDLE IN RESPONSE TO RESISTANCE THIS COULD CONTRIBUTE TO TRIGGER CORD BREAKAGE. THE INSTRUCTIONS FOR USE STATE: IT IS VITAL THAT THE INTEGRITY OF THE WORKING CHANNEL IS INTACT AS GROOVES OR OTHER OBSTRUCTIONS IN THE WORKING CHANNEL CAN POTENTIALLY CAUSE THE STRING TO CATCH, RESULTING IN BAND DEPLOYMENT DIFFICULTIES OR DAMAGE TO THE TRIGGER CORD. THE INSTRUCTIONS FOR USE STATE: USE OF AN ENDOSCOPE IN A SOUND STATE OF REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE. 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 OCCURENCE 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 AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE DEVICE DID NOT DEPLOY THE BANDS AS DIRECTED [THE BANDS WOULD NOT DEPLOY]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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
    393535 6 SHOOTER SAEED MULT-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3558651

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF 180H ENDOSCOPE