BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOEHENDRA LITHOTRIPTOR HANDLE

    MDR report key: 3032693 · Received March 29, 2013

    Report

    Report Number
    1037905-2013-00126
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 1, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    LQC
    PMA / PMN Number
    K902170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE RATCHET BAR FOR WINDING THE DEVICE IS BENT. THE BAR FOR ATTACHING THE CABLE IS ALSO BENT. THE SURFACE OF THE DEVICE HAS BEEN WORN OFF IN SEVERAL PLACES. AS STATED IN THE REPORT "A LOT OF PRESSURE WAS USED TO CRUSH THE STONE." IT APPEARS TO HAVE EXPERIENCED EXTREME FORCE. DURING A LAB MEETING WITH THE SUPPLIER WE CAN CONFIRM THAT THERE ARE NO MFG ISSUES WITH THE DEVICE. THE SUPPLIER BELIEVES THAT EXCESSIVE PRESSURE IS THE CAUSE OF THE DAMAGE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ACCORDING TO THE REPORT, A BASKET OTHER THAN A COOK BASKET WAS USED FOR THE PROCEDURE. THE INSTRUCTIONS FOR USE FOR THIS DEVICE STATES: "ONLY SELECT COOK BILIARY SOFT WIRE BASKETS ARE RECOMMENDED FOR USE WITH THIS DEVICE." THE INSTRUCTIONS FOR USE OF THE SOEHENDRA LITHOTRIPTOR HANDLE WARN THE USER THAT DUE TO THE VARYING COMPOSITIONS OF BILIARY STONES, STONE FRACTURE MAY NOT BE POSSIBLE. IF THE STONE CANNOT BE FRACTURED, CONTINUED ROTATION OF THE HANDLE MAY CAUSE THE BASKET WIRE TO BREAK, REQUIRING SURGICAL INTERVENTION. BREAKAGE OF THE HANDLE CAN OCCUR IF EXCESSIVE PRESSURE IS APPLIED TO THE DEVICE DURING USE. PRIOR TO DISTRIBUTION, ALL COOK DEVICES 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 CORRECTIVE ACTION HAS BEEN IMPLEMENTED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADD'L COMMENTS REGARDING THIS REPORT. BASED ON THE INFO PROVIDED, A COOK REP 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

    A REUSABLE LITHOTRIPSY BASKET FROM OLYMPUS WAS USED TO EXTRACT A STONE. THE STONE WAS TOO BIG TO EXTRACT THROUGH THE PAPILLA. THE COOK SOEHENDRA LITHOTRIPTOR HANDLE AND THE COOK CONQUEST TTC LITHOTRIPTOR CABLE WITH ADAPTER WAS MOUNTED. THE WIRE ON THE OLYMPUS BASKET BROKE OUT FORTUNATELY THE SHORTER COOK SOEHENDRA LITHOTRIPSY CABLE COULD BE MOUNTED. A LOT OF PRESSURE WAS USED TO CRUSH THE STONE. AS SEEN ON THE HANDLE OF THE COOK SOEHENDRA LITHOTRIPTOR HANDLE IT BENT WHERE THE WIRE IS MOUNTED. THE BENDING MAKES IT DIFFICULT TO USE THE HANDLE. AT THE END THE WIRE ON THE BASKET BROKE, BUT NOT AT THE TIP AT THE BASKET. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID REQUIRE AN ADD'L PROCEDURE DUE TO THIS OCCURRENCE. THE ADD'L PROCEDURE WAS SURGERY AS THE WIRE ON THE BASKET DID NOT BREAK AT THE TIP OF THE LITHOTRIPSY BASKET (OLYMPUS). 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
    129804 SOEHENDRA LITHOTRIPTOR HANDLE LQC, LITHOTRIPTER, BILIARY MECHANICAL LQC WILSON-COOK MEDICAL INC. W3205321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COOK SOEHENDRA| LITHOTRIPSY CABLE| OLYMPUS V SCOPE (UNK MODEL NUMBER)| OLYMPUS LITHOTRIPSY BASKET| COOK CONQUEST TTC LITHOTRIPTOR CABLE