BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2231611 · Received August 15, 2011

    Report

    Report Number
    1037905-2011-00540
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    WILSON-COOK MEDICAL
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). THE MEDICAL FACILITY IN (B)(4) INVOLVED IN THIS REPORT IS LISTED. THE CONTACT DETAILS FOR THE COOK FACILITY IN (B)(4) ARE: (B)(4). 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. 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 EVAL. 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 MFG 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. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    IN PREPARATION FOR THE PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LITIGATOR. WHILE LOADING THE LIGATOR DEVICE ONTO THE ENDOSCOPE, BOTH BLUE HOOKS SEPARATED FROM THE LOADING CATHETER. THIS OCCURRED DURING THE LOADING PROCESS; THE DETACHED BLUE HOOK WAS NOT LOCATED INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE OT 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 W2998495

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE