BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI BAND LIGATOR

    MDR report key: 2843817 · Received October 25, 2012

    Report

    Report Number
    1037905-2012-00591
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OF THE THREE (3) DEVICES DESCRIBED, ONLY ONE(1) DEVICE WAS MADE AVAILABLE FOR EVAL; 1037905-2012-00591: RETURNED ON (B)(4) 2012, 1037905-2012-00592: NOT AVAILABLE FOR EVAL, 1037905-2012-00593. 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 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: THE INSTRUCTIONS FOR USE DIRECT THE USER TO ATTACH THE TRIGGER CORD TO THE HOOK ON THE END OF THE LOADING CATHETER, LEAVING APPROX 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 ADD¿L 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. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN IMPLANTED TO REDUCE OCCURRENCES OF BLUE HOOK DETACHMENT. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    IN PREPARATION FOR AN ENDOSCOPY PROCEDURE, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED. THE USER WANTED TO MAKE BANDING WITH THE MBL, BUT THE BLUE HACK [HOOK] PEELED OFF FROM THE [LOADING] CATHETER FROM THE SYSTEM. THE CUSTOMER USED A NEW COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR FROM ANOTHER LOT NUMBER, THIS WAS OK. THE SAME OBSERVATION WAS MADE WITH THREE (3) LIGATORS. SEE MDRS 1037905-2012-00591, 1037905-2012-00592 AND 1037905-2012-00593. THIS OCCURRED DURING THE LOADING PROCESS; THE LOADING CATHETER WAS NOT LOCATED INSIDE THE PT¿S BODY. THE PT DID NOT REQUIRE ANY ADD¿L 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
    1 6 SHOOTER SAEED MULTI BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3145675

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF-145 ENDOSCOPE