BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 3010326 · Received March 13, 2013

    Report

    Report Number
    1037905-2013-00100
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE 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 FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO ENSURE THE BARREL IS ADVANCED AS FAR AS POSSIBLE ONTO THE TIP OF THE ENDOSCOPE AND CAUTIONS THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. THE CAUTION LABEL ON THE DEVICE LISTS THE RECOMMENDED ENDOSCOPE SIZE FOR EACH REORDER NUMBER. THE CAUTION LABEL ON THE DEVICE INSTRUCTS THE USER TO "ENSURE BARREL IS FULLY ADVANCED ONTO TIP OF ENDOSCOPE. FAILURE TO DO SO MAY RESULT IN BARREL BECOMING DISLODGED." THE INSTRUCTIONS FOR USE DIRECT THE USER TO LUBRICATE THE ENDOSCOPE AND EXTERIOR PORTION OF THE BARREL. THE BARREL CAN DISLODGE IF LUBRICANT IS APPLIED TO THE ENDOSCOPE PRIOR TO ATTACHING THE BARREL OR IF LUBRICANT IS ALLOWED INSIDE THE BARREL BEFORE THE LOADING PROCESS. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. PRIOR TO DISTRIBUTION, A 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 AN ENDOSCOPIC VARICEAL LIGATION (EVL) IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. ALL SIX BANDS WERE DEPLOYED SUCCESSFULLY. AT THE END OF THE PROCEDURE WHEN THE ENDOSCOPE WAS BEING REMOVED FROM THE PATIENT, THE LIGATOR BARREL FELL OFF THE ENDOSCOPE AND WAS LOCATED INSIDE THE PATIENT'S THROAT. THE BARREL WAS REMOVED BY THE ENT PHYSICIAN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OTHER THAN REMOVAL OF THE LIGATOR BARREL. 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
    106350 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3228661

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention PENTAX (B)(4) ENDOSCOPE