BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2210155 · Received August 4, 2011

    Report

    Report Number
    1037905-2011-00514
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 5, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: UPON RETURN FOR EVAL, TWO LIGATION BANDS HAD BEEN PREVIOUSLY DEPLOYED AND WERE NOT INCLUDED IN THE RETURN. DURING OUR LAB ANALYSIS, THE LIGATOR BARREL WAS LOADED ONTO AN ENDOSCOPE. ALL REMAINING 8 BANDS DEPLOYED PROPERLY. OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED DID NOT CONFIRM THE REPORT OF PREMATURE BAND DEPLOYMENT. 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: THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL 10 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. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A BAND LITIGATION PROCEDURE, THE PHYSICIAN USED A COOK 10 SHOOTER SAEED MULTI-BAND LIGATOR. TWO BANDS SUDDENLY DEPLOYED IN THE PT'S BODY BEFORE THE PHYSICIAN PLANNED TO RELEASE THE BAND. THE BANDS WERE REMOVED WITH BIOPSY FORCEPS. NO OTHER BANDS WERE REQUIRED TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN 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. LIGATION BANDS ARE INTENDED TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT ONCE THE LIGATION SITE HEALS. THEREFORE, RETRIEVAL OF THE LIGATION BAND FROM THE GASTROINTESTINAL TRACT IS NOT CONSIDERED INTERVENTION TO PRECLUDE SERIOUS INJURY OR DEATH. A REVIEW OF THE ADVERSE EVENT HISTORY FOR THE LIGATOR PRODUCT FAMILY WAS CONDUCTED. RETRIEVAL OF LIGATION BANDS HAS NOT CAUSED OR CONTRIBUTED TO SERIOUS INJURY OR DEATH. THEREFORE, THIS REPORT IS CONSIDERED A MALFUNCTION MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W2975715

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ENDOSCOPE: (UNKNOWN TYPE)