BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1921074 · Received November 11, 2010

    Report

    Report Number
    1037905-2010-00591
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(6) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (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 PRODUCTS FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE 12 MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE ENDOSCOPE ACCESSORY CHANNEL IS COMPROMISED. IN THESE CASES, THE ENDOSCOPE ACCESSORY CHANNEL COLLAPSES, RESTRICTING THE TRIGGER CORD AND PREVENTING PROPER BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING STATEMENT: "THE 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 AND RESULT IN BAND DEPLOYMENT DIFFICULTY. BAND DEPLOYMENT DIFFICULTY CAN OCCUR IF THE TRIGGER CORD IS NOT PROPERLY SEATED IN THE HANDLE ASSEMBLY. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT THE KNOT MUST BE SEATED INTO THE HOLE OR THE HANDLE WILL NOT FUNCTION PROPERLY. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION AND LOOSEN THE TRIGGER CORD SLIGHTLY IF THE BAND WILL NOT DEPLOY. 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 DIRECT THE USER TO REMOVE THE ENDOSCOPE AND ATTACH A NEW LIGATOR IF MORE BANDS ARE REQUIRED. SLIPPAGE OF THE BAND FROM THE VARICES CAN OCCUR IF THE ENDOSCOPE IS ADVANCED BEYOND THE BANDED SITE. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT PASSING THE ENDOSCOPE OVER A PREVIOUSLY PLACED BAND MAY DISLODGE THE BAND. PRIOR TO DISTRIBUTION, 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 THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN IMPLEMENTED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL BAND LIGATION PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY 4 SHOOTER SAEED MULTI-BAND LIGATOR. FRICTION IN DEPLOYING THE FIRST BAND WAS REPORTEDLY HIGHER THAN NORMAL. THE SECOND BAND COULD ONLY BE DEPLOYED WITH WHAT WAS REPORTED TO BE A HIGHER FORCE THAN NORMAL AND THE BAND SLID OFF. THE BLEEDING WAS STOPPED WITH THE THIRD BAND. THE FOURTH BAND COULD NOT BE RELEASED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L 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 4 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2787054

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR OLYMPUS GIF-Q160 GASTROSCOPE