BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2093002 · Received April 15, 2011

    Report

    Report Number
    1037905-2011-00236
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 17, 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

    LIGATION BANDS ARE INTENDED TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT ONCE THE LIGATION SITE HEALS. THEREFORE, RETRIEVAL OF A LIGATION BAND FROM THE GASTROINTESTINAL TRACT IS NOT CONSIDERED INTERVENTION TO PRECLUDE SERIOUS INJURY OR DEATH. A REVIEW OF THE TWO YEAR ADVERSE EVENT HISTORY FOR THE LIGATOR PRODUCT FAMILY WAS CONDUCTED. RETRIEVAL OF LIGATION BANDS HAS NOT CAUSED OR CONTRIBUTED TO SERIOUS INJURY OR DEATH DURING THIS TIME PERIOD. EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. THE LIGATOR BARREL WAS RETURNED WITH FIVE BANDS REMAINING IN POSITION. THE LIGATOR HANDLE WAS RETURNED IN THE FIRING POSITION AND FUNCTIONED PROPERLY. DURING OUR LABORATORY ANALYSIS, THE LIGATOR WAS LOADED ONTO AN ENDOSCOPE THAT IS IN A CURVED POSITION TO SIMULATE WORST-CASE SCENARIO. THE FIVE REMAINING BANDS DEPLOYED PROPERLY. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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. 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 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 LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING ESOPHAGEAL BANDING, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE REPORTER INDICATED THE LATEX BAND CAME OFF IN THE PT DURING THE PROCEDURE (I.E. PREMATURE BAND DEPLOYMENT). THE BAND WAS REMOVED WITH BIOPSY FORCEPS. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO 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 INC. W2873833

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR ENDOSCOPE (UNKNOWN TYPE)