BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 4792544 · Received May 20, 2015

    Report

    Report Number
    1037905-2015-00201
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 20, 2015
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: DURING THE LABORATORY EVALUATION, THE REPORT COULD NOT BE CONFIRMED. THE TRIGGER CORD, TWO-WAY HANDLE, BARREL, AND THREE BANDS WERE RETURNED. THE BEADS WERE VERIFIED FOR CORRECT LOCATION. THE LENGTH OF THE TRIGGER CORD WAS MEASURED WITHIN SPECIFICATION. THE TRIGGER CORD WAS INTACT AND NOT BROKEN. A DIMENSIONAL VERIFICATION OF THE FRICTION FIT PORTION OF THE ADAPTER WAS PERFORMED USING A GAUGE REPRESENTING THE SMALLEST ENDOSCOPE SIZE. THE BARREL ACCEPTED AND FIT SECURELY ON THE GAUGE. THE FRICTION FIT MATERIAL SHOWS NO SIGNS OF DAMAGE OR SEPARATION. THE USER DID NOT PROVIDE THE COMPLETE SCOPE MODEL NUMBER SO COMPATIBILITY COULD NOT BE DETERMINED. A PRODUCT SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE SUBASSEMBLY DEVICE HISTORY RECORD FOR THE STRING WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. THE SUBASSEMBLY DEVICE HISTORY RECORD FOR THE BARREL WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. IN ADDITION, DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IT IS A MISCONCEPTION THAT THE TRIGGER CORD REMAINS ATTACHED TO THE BARREL AFTER ALL BANDS HAVE BEEN DEPLOYED. THE TRIGGER CORD AND BARREL ARE SEPARATE COMPONENTS AND ARE NOT INTENDED TO BE ATTACHED OR CONNECTED. LABELING ON THE DEVICE LISTS THE RECOMMENDED ENDOSCOPE SIZE FOR EACH RE-ORDER NUMBER. USE OF THE PRODUCT WITH AN ENDOSCOPE TOO LARGE OR TOO SMALL CAN RESULT IN THE BARREL BECOMING DISLODGED. THE CAUTION LABEL ON THE DEVICE INSTRUCTS THE USER TO "ENSURE BARREL IS FULLY ADVANCED ONTO TIP OF ENDOSCOPE. FAILURE TO DO SO MAY RESULT IN BARREL BECOMING DISLODGED". THE INSTRUCTIONS FOR USE DIRECT THE USER TO LUBRICATE THE ENDOSCOPE AND EXTERIOR PORTION OF THE BARREL. THE BARREL CAN DISLODGE IF LUBRICANT IS APPLIED TO THE ENDOSCOPE PRIOR TO ATTACHING THE BARREL OR IF LUBRICANT IS ALLOWED INSIDE THE BARREL BEFORE THE LOADING PROCESS. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. 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 FOR THE LOT NUMBER CONFIRMED THAT THIS LOT 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, THE TRIGGER CORD OF A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR IS CUT AND THE BARREL FELL OUT FROM THE ENDOSCOPE [OFF OF THE ENDOSCOPE AND INTO THE PATIENT]. AFTER REMOVING THE ENDOSCOPE, THE BARREL MOVED FROM THE ESOPHAGUS TO ORAL [MOUTH]. IT HAD A RISK TO PASS THE AIR WAY [OBSTRUCT THE AIRWAY]. THE PHYSICIAN USED ANOTHER DEVICE AND REMOVED IT [BARREL]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. OTHER THAN REMOVING THE BARREL, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL 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
    327547 6 SHOOTER SAEED MULTI-BAND LIGATOR LIGATOR ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3513156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS GIF - 180 ENDOSCOPE