BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIX SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1063521 · Received June 18, 2008

    Report

    Report Number
    1037905-2008-00077
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 22, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. 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 RARE. CONCLUSIONS: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE DEVICE WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. 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 INSTRUCTION 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 SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG 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 THE ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. 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 SIX SHOOTER SAEED MULTI-BAND LIGATOR. DURING USE, TWO BANDS DEPLOYED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED WITH USING THIS DEVICE. 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 SIX SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2471763

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK