BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1211272 · Received October 16, 2008

    Report

    Report Number
    1037905-2008-00133
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. 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 INFORMATION, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION, BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. 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). THE INSTRUCTIONS FOR USE ADVISE THE USER THAT REMOVAL OF THE ENDOSCOPE AND ATTACHMENT OF ANOTHER LIGATOR MAY BE REQUIRED IF MORE BANDS ARE NEEDED. 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 ACTIONS: NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. 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 FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL BANDING PROCEDURE 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 NOT DEPLOY. THE ENDOSCOPE AND LIGATOR WERE WITHDRAWN FROM THE PATIENT AND TWO BANDS WERE DEPLOYED MANUALLY. THE LIGATOR WAS ADVANCED INTO POSITION AND THE REMAINING FOUR BANDS WERE DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING THIS LIGATOR. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT 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 MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2579112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN