BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 3760849 · Received April 4, 2014

    Report

    Report Number
    1037905-2014-00120
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    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 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 CONCLUSIONS: 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. 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. 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 TO COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL BANDING PROCEDURE, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED. ALL OF THE BANDS FIRED AT ONCE AFTER BEING ATTACHED TO THE ENDOSCOPE. SOME OF THE BANDS WERE LOCATED IN THE STOMACH AND ESOPHAGUS. FOUR (4) OF THE BANDS WERE LOCATED IN THE OROPHARYNX. FORCEPS AND SUCTION EQUIPMENT WERE USED TO REMOVE THE BANDS FROM THE OROPHARYNX, THE OTHERS WERE LEFT TO PASS. ANOTHER COOK LIGATOR WAS USED TO COMPLETE THE INITIAL PROCEDURE. NO HARM WAS DONE TO THE PATIENT. OTHER THAN THE DEPLOYED BANDS LEFT TO PASS, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. FORCEPS AND SUCTION WERE USED FOR REMOVAL OF FOUR (4) DEPLOYED BANDS IN THE OROPHARYNX. THE PATIENT DID NOT REQUIRE ANY OTHER ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203751 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3357196

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Required Intervention OLYMPUS GIF Q160 ENDOSCOPE