BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1191231 · Received September 24, 2008

    Report

    Report Number
    1037905-2008-00128
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Report Date
    August 26, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THAT ALL OF THE BANDS HAD BEEN DEPLOYED FROM THE LIGATOR BARREL. THEREFORE, THE REPORT OF PREMATURE BAND DEPLOYMENT COULD NOT BE CONFIRMED. DUE TO THE CONDITION OF THE RETURNED LIGATOR, WE WERE UNABLE TO PERFORM A FUNCTIONAL EVAL RELATING TO BAND DEPLOYMENT. THE LIGATOR HANDLE WAS RETURNED IN THE TWO-WAY POSITION. DURING OUR EVAL, THE LIGATOR HANDLE WAS 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 LIGATOR. 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 PROD FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITION COULD NOT BE DUPLICATED IN THE LAB 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: 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 INSTRUCTION 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 4 SHOOTER SAEED 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 MFR REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION 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 ENDOSCOPIC BANDING PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY 4 SHOOTER SAEED MULTI-BAND LIGATOR. THE BANDS PREMATURELY DEPLOYED INSIDE THE PT. ANOTHER LIGATOR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2551432

    Patients

    Seq Age Sex Outcome Treatment
    1