BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1982767 · Received January 6, 2011

    Report

    Report Number
    1037905-2011-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ONE BLUE HOOK HAS SEPARATED FROM ONE END OF THE LOADING CATHETER. THE INNER DIAMETER OF THE LOADING CATHETER WAS VERIFIED WITH A PIN GAUGE AND WAS FOUND TO BE WITHIN SPECIFICATION. THE BLUE HOOK THAT DETACHED WAS NOT INCLUDED IN THE RETURN. NO KINKS OR BENDS WERE NOTED IN THE LOADING CATHETER. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO BLUE HOOK SEPARATION FROM THE LOADING CATHETER WAS NOT OBSERVED DURING OUR ANALYSIS OF THE RETURNED PRODUCT. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THE TYPE OF REPORT IS RARE. CONCLUSIONS: 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. 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 CORRECTIVE ACTION HAS BEEN IMPLEMENTED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    IN PREPARATION FOR HEMORRHOIDAL BANDING, THE PHYSICIAN SELECTED A COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE LOADING CATHETER WAS USED TO LOAD THE LIGATOR BARREL ONTO THE ENDOSCOPE BEFORE INSERTING THE ENDOSCOPE (WITH LOADED LIGATOR) INTO THE PT. DURING THE LOADING PROCESS, THE SMALL BLUE HOOK LOCATED ON THE END OF THE LOADING CATHETER SEPARATED FROM THE LOADING CATHETER. THE LOADING CATHETER HAS A SMALL BLUE HOOK AT EACH END SO THE USER WAS ABLE TO USE THE OPPOSITE END OF THE LOADING CATHETER TO SUCCESSFULLY LOAD THE LIGATOR BARREL ONTO THE ENDOSCOPE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, HEMORRHOIDAL MND COOK ENDOSCOPY W2889538

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF-180 ENDOSCOPE