BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2913098 · Received January 8, 2013

    Report

    Report Number
    1037905-2013-00011
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 29, 2012
    Report Date
    December 10, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM. THE RETURNED TRAY CONSISTED OF ONE CATHETER WITH BOTH BLUE HOOKS ATTACHED AND FULLY SEATED. WE ARE UNABLE TO DETERMINE IF THE BLUE HOOKS HAD SEPARATED AND WERE REPOSITIONED WITHIN THE CATHETER BY THE CUSTOMER. THE HANDLE WITH TRIGGER CORD ATTACHED AND A LOOSE BARREL WITH NO BANDS ATTACHED WAS INCLUDED WITH THE RETURN. THE LENGTH OF THE LOADING CATHETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. NO KINKS OR BENDS WERE NOTED. MOVEMENT OF THE HANDLE WHEEL WAS PERFORMED AND FUNCTIONED AS INTENDED. THE STRING WAS DISMANTLED FROM THE MBL ASSEMBLY TO INVESTIGATE THE INTEGRITY OF THE STRING AND THE BEADS. IT WAS NOTED THAT THE STRING WAS FULLY INTACT AND CONTAINED ONE DOUBLE TIED KNOT AT THE END. TWO GROUPS OF 6 SETS OF BEADS WERE ATTACHED TO THE STRING. THE PRODUCT IS SOLD WITH TWO SETS OF 6 BEADS (TOTAL 12 BEADS). BEAD MOLD INTEGRITY - THE BEADS WERE EXAMINED USING MAGNIFICATION AND FOUND TO BE FILLED AND NO EVIDENCE OF EXCESS FLASH WAS OBSERVED. THE STRING LENGTH WAS MEASURED FROM THE KNOT TO THE BEAD END USING A CALIBRATED DEVICE - T2523 FIXTURE AND FOUND TO BE WITHIN SPECIFICATION. THE TOTAL LENGTH OF THE STRING WAS ALSO MEASURED FROM PROXIMAL TO DISTAL KNOT. BEADS WERE LOCATED IN THE SPECIFIC GROOVE FOR CORRECT PLACEMENT AND ARE THUS WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO 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 AS THE RETURNED PRODUCT PASSED THE VISUAL AND DIMENSIONAL VERIFICATIONS. THE ACTUAL USE CONDITION COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ATTACH THE TRIGGER CORD TO THE HOOK ON THE END OF THE LOADING CATHETER, LEAVING APPROXIMATELY 2 CM OF TRIGGER CORD BETWEEN THE KNOT AND THE HOOK. IF THE KNOT AND THE HOOK ARE PLACED CLOSER THAN 2 CM, THIS CAN CREATE RESISTANCE WHEN WITHDRAWING THE LOADING CATHETER THROUGH THE LIGATOR HANDLE AND/OR ACCESSORY CHANNEL OF THE ENDOSCOPE. IF ADDITIONAL PRESSURE IS APPLIED TO THE LOADING CATHETER WHEN RESISTANCE IS ENCOUNTERED, THIS COULD CONTRIBUTE TO SEPARATION OF THE BLUE HOOK FROM THE LOADING CATHETER. 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 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.

    Description of Event or Problem · 1

    A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS SELECTED BY THE USER. PRIOR TO PT CONTACT, THE THREAD FAILED. [THE LOADING CATHETER IS USED TO THREAD THE LIGATOR CORD THROUGH THE ENDOSCOPE AND THIS DESCRIPTION REASONABLY SUGGESTS THE BLUE HOOK MAY HAVE SEPARATED DURING THE LOADING PROCESS]. THIS OCCURRED DURING THE LOADING PROCESS; THE LOADING CATHETER WAS NOT LOCATED INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTED, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9259 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3176947

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)