BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MUTI-BAND LIGATOR

    MDR report key: 4213428 · Received October 24, 2014

    Report

    Report Number
    1037905-2014-00418
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 25, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: THE REPORT BY THE USER THAT THE TRIGGER CORD HAD BROKEN WAS NOT CONFIRMED. THE TRIGGER CORD MEASURED 122 CM WHICH IS WITHIN THE MFG SPECS. THE LOCATION OF THE BEADS WERE VERIFIED WHICH ALSO CONFIRMS THE REMAINING LENGTH OF THE TWO STRING LEGS. UPON RECEIVING THE PRODUCT IT WAS OBSERVED THAT ONE BLUE HOOK HAS SEPARATED FROM THE LOADING CATHETER AND THAT THE BLUE HOOK WAS NOT INCLUDED IN THE RETURN. THE INNER DIAMETER OF THE CATHETER WHERE THE BARB WAS INSERTED WAS INSPECTED USING PIN GAUGES AND FOUND THAT THERE IS A SUFFICIENT INTERFERENCE FIT BETWEEN THE HOOK AND TUBING. THE RECESSED PORTION OF THE STIFFENING WIRE INSIDE THE END OF THE TUBING WAS MEASURED AND INDICATED THAT THE STIFFENING WIRE DID NOT INTERFERE WITH INSERTION OF THE BLUE HOOK. APPROX 2 CM OF TUBING WAS CUT OFF AND THE CUT END WAS PIN GAUGED. THE INNER DIAMETER OF THE TUBING AT THIS POINT WAS PIN GAUGED AND FOUND TO BE WITHIN THE TOLERANCE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. THE TWO POSSIBLE LOT NUMBERS FOR THE LOADING CATHETER SUBASSEMBLY WERE 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 LAB SETTING. 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 APPROX 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 ADD'L 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 RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG 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. QA 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

    IN PREPARATION FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE STRING BROKE WHEN PULLING IT THROUGH THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE OF THE SAME TYPE. THE DEVICE WAS RECEIVED AT COOK FOR EVAL ON (B)(6) 2014. THE TRIGGER CORD OF THE DEVICE IS NOT BROKEN. OUR LAB EVAL DETERMINED THE BLUE HOOK IS SEPARATED FROM THE LOADING CATHETER AND WAS NOT INCLUDED IN THE RETURN. INFO REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. INFO PROVIDED INDICATED THE STAFF THROUGH THE TRIGGER CORD HAD BROKEN. THEY DIDN'T SEE THE BLUE HOOK IN THE ENDOSCOPE OR PT AFTER THE PROCEDURE WAS FINISHED. THE LOCATION OF THE BLUE HOOK IS UNK. THIS OCCURRED DURING THE LOADING PROCESS, THE LOADING CATHETER WAS NOT LOCATED 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
    680874 6 SHOOTER SAEED MUTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3203487

    Patients

    Seq Age Sex Outcome Treatment
    1