BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2231625 · Received August 15, 2011

    Report

    Report Number
    1037905-2011-00537
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    IN PREPARATION FOR A BAND LIGATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE USER WAS UNABLE TO LOAD THAT LIGATOR ONTO THE ENDOSCOPE BECAUSE THE BLUE HOOK SEPARATED FROM THE LOADING CATHETER AND WAS LOCATED INSIDE THE ENDOSCOPE. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE (REFERENCE MDR # 1037905-2011-00537). ANOTHER COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR FROM THE SAME LOT NUMBER WAS LOADED ONTO THE ENDOSCOPE. HOWEVER, THE BLUE HOOK SEPARATED FROM THE LOADING CATHETER AS WELL (REFERENCE MDR # 1037905-2011-00538). A THIRD COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED TO SUCCESSFULLY PERFORM THE PROCEDURE. THIS OCCURRED DURING THE LOADING PROCESS; THE LOADING CATHETER WAS NOT LOCATED INSIDE THE PATIENT'S BODY. NO HARM TO THE PATIENT OCCURRED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT 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. W3019819

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS UPPER ENDOSCOPE (UNKNOWN TYPE)