BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 3173483 · Received June 11, 2013

    Report

    Report Number
    1037905-2013-00384
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    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. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ATTACH THE TRIGGER CORD TO THE HOOK ON THE END OF THE LOADING CATHETER, LEAVING APPROXIMATELY 2CM 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 ADDITIONAL 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 TO ENSURE DEVICE INTEGRITY. 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 THE PROCEDURE, THE USER SELECTED TWO COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. SEE MDR 1037905-2013-00385. FOR EACH DEVICE, THE KNOT ON THE STRING ATTACHED TO THE BARREL WAS TOO LARGE AND WOULD NOT FIT THROUGH THE METAL PORTION OF THE HANDLE DURING THE LOADING PROCESS. THIS CAUSED THE HOOKS ON THE LOADING CATHETER TO BREAK. WHILE THE DOCTOR ATTEMPTED TO FIX THE DEVICE, THE PT VOMITED BLOOD. ANOTHER TWO LIGATION DEVICES WERE USED AND TO FINISH PROCEDURE. THIS OCCURRED DURING THE LOADING PROCESS; THE LOADING CATHETER WAS NOT LOCATED INSIDE THE PT'S BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THERE WERE NO ADVERSE EFFECTS DUE TO THIS OCCURRENCE OTHER THAN THE PT GETTING SICK WHILE THE PHYSICIAN ATTEMPTED TO FIX THE DEVICE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264189 6 SHOOTER SAEED MULTI-BAND LIGATOR MND WILSON-COOK MEDICAL INC UNK

    Patients

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