BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1922857 · Received November 12, 2010

    Report

    Report Number
    1037905-2010-00611
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE ENDOSCOPE TIP IN A STRAIGHT POSITION DURING THE LOADING PROCESS. LOADING THE BARREL AND TRIGGER CORD WITH THE ENDOSCOPE TIP CURVED CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. PREMATURE BAND DEPLOYMENT CAN OCCUR IF CARE IS NOT EXERCISED WHILE LOADING THE DEVICE ONTO THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO SLOWLY ROTATE THE HANDLE CLOCKWISE TO WIND THE TRIGGER CORD ONTO THE HANDLE SPOOL UNTIL IT IS TAUT. THE INSTRUCTIONS ADVISE THE USER THAT CARE MUST BE TAKEN TO AVOID PREMATURE BAND DEPLOYMENT WHEN WINDING THE TRIGGER DURING SYSTEM PREPARATION. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS PLACED IN THE FIRING POSITION BEFORE THE ENDOSCOPE IS IN PLACE INSIDE THE PT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO KEEP THE HANDLE IN THE TWO-WAY POSITION PRIOR TO INTRODUCING THE ENDOSCOPE. AFTER INTUBATION, THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE FIRING POSITION. RAPID ROTATION OF THE LIGATOR HANDLE CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO MAINTAIN SUCTION AND DEPLOY THE BAND BY ROTATING THE HANDLE CLOCKWISE UNTIL BAND RELEASE IS FELT. 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. IF THE LIGATOR HANDLE IS IN THE FIRING POSITION WHILE THE ENDOSCOPE IS STRAIGHTENED, THIS CAN RESULT IN PREMATURE BAND DEPLOYMENT DUE TO TENSION ON THE TRIGGER CORD. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION BEFORE STRAIGHTENING THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO REMOVE THE ENDOSCOPE AND ATTACH A NEW LIGATOR IF MORE BANDS ARE REQUIRED. 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 THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN IMPLEMENTED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MFG PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. NO FURTHER ACTION IS WARRANTED AT THIS TIME 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 AN ENDOSCOPIC BAND LIGATION PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE CUSTOMER REPORTED THE BANDS DEPLOYED INSIDE THE LIGATOR BARREL AND NOT AROUND THE VARICES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2874896

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR OLYMPUS GIF-180 ENDOSCOPE