BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MUTLI-BAND LIGATOR

    MDR report key: 1120464 · Received August 14, 2008

    Report

    Report Number
    1037905-2008-00106
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 16, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED. WE WERE UNABLE TO SUBJECT THE LIGATOR TO A FUNCTIONAL TEST BECAUSE ALL THE BANDS HAD BEEN DEPLOYED FROM THE LIGATOR BARREL. ONE BAND WAS RETURNED SEPARATE FROM THE LIGATOR BARREL. THE HANDLE WAS RETURNED IN THE FIRING POSITION AND FUNCTIONED PROPERLY. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR ANALYSIS OF THE RETURNED PRODUCT. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE DEVICES WERE PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE CANNOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. WHILE CLINICAL CONDITIONS ARE NOT THE SOLE DETERMINING FACTORS, THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE THE CAUSE FOR THIS OBSERVATION. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE ENDOSCOPE ACCESSORY CHANNEL IS COMPROMISED. IN THESE CASES, THE ENDOSCOPE ACCESSORY CHANNEL COLLAPSES, CONSTRICTING THE TRIGGER CORD AND PREVENTING PROPER BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT USE OF AN ENDOSCOPE IN A SOUND STATE OF REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO BAND DEPLOYMENT DIFFICULTY INCLUDES ALLOWING THE TRIGGER CORD TO BECOME LODGED BETWEEN THE BARREL AND THE DISTAL END OF THE ENDOSCOPE. THIS CAN RESTRICT TRIGGER CORD MOVEMENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION AND LOOSEN THE TRIGGER CORD NEAR THE HANDLE IF BAND DEPLOYMENT DIFFICULTIES ARE ENCOUNTERED. THE USER IS THEN INSTRUCTED TO RETURN THE HANDLE TO THE FIRING POSITION AND CONTINUE WITH DEPLOYMENT OF THE BAND(S). PRIOR TO DISTRIBUTION, ALL MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO FURTHER ACTION IS WARRANTED BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ENDOSCOPY SIX SHOOTER SAEED MULTI BAND LIGATOR. THE DEVICE WAS LOADED ONTO THE ENDOSCOPE AND ADVANCED INTO POSITION. WHEN THE HANDLE WAS TURNED THE BANDS WOULD DEPLOY. THE ENDOSCOPE AND LIGATOR WERE REMOVED FROM THE PT. ANOTHER BANDING KIT WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 SHOOTER SAEED MUTLI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2540632

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR