BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 4110286 · Received September 12, 2014

    Report

    Report Number
    1037905-2014-00350
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Report Date
    August 15, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS RESEARCHED TO DETERMINE THE MFG DATE OF THE ACTUAL BANDS. WE CAN CONCLUDE FROM THESE DATES THAT THE BANDS WERE WITHIN THE ACCEPTABLE AGE DATE RANGE TO ENSURE THE BANDS MAINTAIN THEIR ELASTICITY PROPERTIES. THE TRIGGER CORD SUB ASSEMBLY DEVICE HISTORY RECORD WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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 EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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 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 ENDO 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 THE ESOPHAGOGASTRODUODENOSCOPY (EGD), A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED TO BAND ESOPHAGEAL VARICES. MULTIPLE BANDS WERE DEPLOYING AT ONE TIME. ANOTHER OF THE SAME DEVICE WAS USED TO COMPETE THE PROCEDURE. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ADDITIONAL 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
    566701 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, HEMORRHOIDAL MND WILSON-COOK MEDICAL INC. W3419453

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)