BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 4240329 · Received October 30, 2014

    Report

    Report Number
    1037905-2014-00423
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. TWO POSSIBLE SUB ASSEMBLY WORK ORDERS FOR THE FRICTION FIT ADAPTER WERE 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. LABELING ON THE DEVICE LISTS THE RECOMMENDED ENDOSCOPE SIZE FOR EACH MULTI-BAND LIGATOR DEVICE. USE OF THE PRODUCT WITH AN ENDOSCOPE TOO LARGE OR TOO SMALL CAN RESULT IN THE BARREL BECOMING DISLODGED. 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, 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 THIS LOT 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 ESOPHAGEAL VARICES BANDING PROCEDURE, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED. THE STRING WITHIN THE ENDOSCOPE BROKE, DETACHING THE BARREL INTO THE PT AND CAUSING THE BANDS TO DISLODGE. THE BARREL WAS RETRIEVED USING A POUCH DEVICE WHILE THE BANDS WERE LEFT TO PASS NATURALLY. A SECOND BANDING PROCEDURE WAS REQUIRED TO REPLACE THE DISLODGED BANDS. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE SECOND PROCEDURE SUCCESSFULLY. THE BARREL WAS RETRIEVED USING A POUCH DEVICE. THE DEPLOYED BANDS WERE LEFT TO PASS NATURALLY. NO OTHER SECTION OF THE DEVICE REMAINED INSIDE THE PT'S BODY. OTHER THAN A SECOND PROCEDURE TO COMPLETE THE ORIGINALLY INTENDED PROCEDURE, THE PT DID NOT REQUIRE ANY OTHER ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE NOTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695253 6 SHOOTER SAEED MULTI-BAND LIGATOR MND - LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3468008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOSCOPE, MODEL NO: UNK