BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 6776530 · Received August 9, 2017

    Report

    Report Number
    1037905-2017-00531
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 18, 2017
    Report Date
    August 9, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    UDI-DI
    00827002246546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS RESEARCHED TO DETERMINE THE EXPIRATION DATE OF THE ACTUAL BANDS. WE CAN CONCLUDE FROM THESE DATES THAT THE BANDS WERE USED WITHIN THE ACCEPTABLE AGE DATE RANGE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE ADDITIONAL INFORMATION PROVIDED STATES THAT AN OLYMPUS GIF H190 ENDOSCOPE WAS USED, WHICH HAS AN OUTER DIAMETER OF 9.2 MM. THIS LIGATOR (MBL-6-OV) IS NOT COMPATIBLE WITH THE ENDOSCOPE USED IN THE PROCEDURE. THIS LIGATOR IS COMPATIBLE WITH ENDOSCOPES THAT HAVE AN OUTER DIAMETER OF 9.5 MM-11.3 MM ONLY. USE OF AN INCORRECT ENDOSCOPE CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. APPLYING TENSION TO THE TRIGGER CORD DURING SYSTEM PREPARATION CAN RESULT IN PREMATURE BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING: "NOTE: CARE MUST BE TAKEN TO AVOID DEPLOYING A BAND WHILE WINDING TRIGGER CORD." PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS PLACED IN THE FIRING POSITION BEFORE THE ENDOSCOPE IS IN PLACE INSIDE THE PATIENT OR EVEN WHILE WINDING THE TRIGGER CORD. THE INSTRUCTIONS FOR USE CAUTION THE USER: ¿WITH HANDLE IN TWO WAY POSITION, SLOWLY ROTATE HANDLE CLOCKWISE TO WIND TRIGGER CORD ONTO HANDLE SPOOL UNTIL IT IS TAUT. NOTE: CARE MUST BE TAKEN TO AVOID DEPLOYING A BAND WHILE WINDING TRIGGER CORD." ANOTHER POSSIBLE CONTRIBUTING FACTOR TO PREMATURE BAND DEPLOYMENT 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 PREMATURE BAND DEPLOYMENT IF ENOUGH TENSION IS APPLIED TO PULL THE CORD FREE. RAPID ROTATION OF THE LIGATOR HANDLE CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE DIRECT THE USER: ¿MAINTAIN SUCTION AND DEPLOY BAND BY ROTATING HANDLE CLOCKWISE UNTIL BAND RELEASE IS FELT, INDICATING DEPLOYMENT." PRIOR TO DISTRIBUTION, ALL 6 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT AN INCOMPATIBLE ENDOSCOPE WAS USED WITH THE MBL-6 OV, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH VARICEAL BANDING, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE FIRST BANDER WAS PUT ON AND ONE BAND WAS SUCCESSFULLY DEPLOYED. UPON TRYING TO DEPLOY A SECOND BAND ON A NEW SITE, ALL THE BANDS FIRED OFF OF THE BARREL AT ONCE[PREMATURE BAND DEPLOYMENT](SEE RELATED MDR 1037905-2017-00530). THE BANDS WERE LEFT TO PASS NATURALLY. A SECOND DEVICE WAS USED FOR ADDITIONAL BANDS, AND ONE BAND WAS PLACED SUCCESSFULLY AND THE REMAINING BANDS FIRED OFF SPORADICALLY [PREMATURE BAND DEPLOYMENT](SUBJECT OF THIS REPORT). THE NURSE AND TECH IN THE ROOM OBSERVED THE PHYSICIAN PREP THE DEVICE AND STATED IT APPEARED THAT EVERYTHING WAS DONE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561722 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY 00827002246546

    Patients

    Seq Age Sex Outcome Treatment
    1