BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIX SHOOTER MULTI-BAND LIGATOR (DEVICE 1 OF 2)

    MDR report key: 1022721 · Received March 26, 2008

    Report

    Report Number
    1037905-2008-00034
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVALUATION OF THE RETURNED DEVICES CONFIRMED THAT ALL OF THE BANDS PREVIOUSLY DEPLOYED FROM THE LIGATOR BARRELS. HOWEVER, THE REPORTED PREMATURE BAND DEPLOYMENT WAS UNABLE TO BE CONFIRMED. WE WERE UNABLE TO PERFORM A FUNCTIONAL EVALUATION RELATING TO BAND DEPLOYMENT BECAUSE THE LIGATOR BANDS AND TRIGGER CORDS WERE NOT INCLUDED IN THE RETURN. THE LIGATOR HANDLES WERE RETURNED IN THE TWO-WAY POSITION. DURING OUR EVALUATION, THE LIGATOR HANDLES WERE INSPECTED AND FUNCTIONED PROPERLY. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION OF PREMATURE BAND DEPLOYMENT WAS NOT OBSERVED DURING OUR ANALYSIS OF THE RETURNED LIGATORS. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THESE LOT NUMBERS, 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 RARE. 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 CAN NOT REPRODUCE THA 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: THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO DEPLOY THE BAND BY ROTATING THE HANDLE CLOCKWISE UNTIL BAND RELEASE IS FELT, INDICATING DEPLOYMENT. ROTATING THE HANDLE IN A RAPID FASHION COULD HAVE CAUSED MISFIRING OR PREMATURE DEPLOYMENT OF THE BANDS. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE DOES NOT REMAIN IN THE TWO-WAY POSITION UNTIL READY FOR BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO KEEP THE HANDLE IN THE TWO-WAY POSITION BEFORE AND DURING INTRODUCTION OF THE ENDOSCOPE. AFTER THE ENDOSCOPE IS IN PLACE, THE USER IS THEN INSTRUCTED TO PLACE THE HANDLE IN THE FIRING POSITION. DURING THE PROCEDURE, ENDOSCOPIC SUCTION IS APPLIED TO THE BANDING SITE TO PROPERLY PLACE A LIGATOR BAND. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS ROTATED BEFORE MAINTAINING SUCTION ON THE BANDING SITE. THE INSTRUCTIONS FOR USE ADVISE THE USER TO MAINTAIN SUCTION WHILE DEPLOYING THE BAND. 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 SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THESE LOTS MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT OF PREMATURE BAND DEPLOYMENT COULD NOT BE CONFIRMED. 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BANDING OF ESOPHAGEAL VARICES, THE PHYSICIAN USED A COOK ENDOSCOPY SIX SHOOTER MULTI-BAND LIGATOR. THE USER REPORTED THAT THE LIGATOR MISFIRED AND TWO BANDS RELEASED AT THE SAME TIME. ANOTHER BANDER WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION. THE USER FACILITY INDICATED THE SAME OBSERVATION WAS MADE ON ANOTHER SIX SHOOTER MULTI-BAND LIGATOR (DEVICE 2). THE OBSERVATIONS AND OUTCOME ARE IDENTICAL TO DEVICE 1. FOR SUSPECT MEDICAL DEVICE INFO ON DEVICE 2, SEE REPORT NUMBER 1037905-2008-00035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIX SHOOTER MULTI-BAND LIGATOR (DEVICE 1 OF 2) MND LIGATOR ESOPHAGEAL MND COOK ENDOSCOPY NA W2489034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK