BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1950024 · Received December 6, 2010

    Report

    Report Number
    1037905-2010-00684
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Report Date
    November 6, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. 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 THIS 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 CORRECTION ACTION HAS BEEN INITIATED 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. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    IN PREPARATION FOR A BANDING PROCEDURE TO LIGATE ESOPHAGEAL VARICES, THE PHYSICIAN SELECTED A COOK ENDOSCOPY 4 SHOOTER SAEED MULTI-BAND LIGATOR. THE USER REPORTED THE BLUE HOOK SEPARATED FROM THE LOADING CATHETER DURING THE LOADING PROCESS WHEN THE LOADING CATHETER WAS PULLED THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE. A SECTION OF THE DEVICE DID NOT DETACH INSIDE THE PT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADDITIONAL INFO REGARDING PT IMPACT. THE COMPLAINANT DID NOT SPECIFY IF THE PT REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT. HOWEVER, THE INFO ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2863923

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)