BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUCKBILL D-TOUCH DISSECTOR 5MM 45CMRATCH

    MDR report key: 3919980 · Received July 8, 2014

    Report

    Report Number
    1038548-2014-00042
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K930667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE WAS RECEIVED FOR EVALUATION FOR THE INSTRUMENT SPRUNG OPEN DURING THE CASE AND THE NEEDLE WAS TEMPORARILY LOST IN THE PATIENT. THE DEVICE HAD A DATE CODE OF C13. IT WAS CONFIRMED TO BE MANUFACTURED MARCH 01, 2013 UNDER LOT NUMBER 853285. THE DEVICE WAS EVALUATED BY THE IN-HOUSE REPAIR DEPARTMENT, QUALITY CONTROL FINAL TECHNICIAN, AND PRODUCT ENGINEER WHO DID NOT CONFIRM THE REPORTED ISSUE. VISUAL AND FUNCTIONAL EXAMINATION REVEALED THAT THE DEVICE RATCHET LOCK MECHANISM WAS DRY, RESULTING IN IT BEING DIFFICULT TO PLACE IN THE ¿LOCKED¿ POSITION. THE DEVICE REQUIRED LUBRICATION. UPON SLIGHTLY LUBRICATING THE RATCHET LOCK, IT WAS ABLE TO MOVE BACK AND FORTH WITH MORE EASE. IN ORDER FOR THE DEVICE TO WORK PROPERLY BY OPENING AND CLOSING THE JAW, THE USER NEEDS TO FULLY UNLOCK THE RATCHET LOCK BY SLIDING IT OVER COMPLETELY TO THE RIGHT POSITION FULLY UNLOCKING THE RATCHET AND ALLOWING THE RATCHET TO ENGAGE, THEN RATCHET DOWN TO THE CLOSE POSITION SECURING JAW. BY PUSHING THE THUMB BUTTON DOWN IT RELEASES THE RATCHET MOMENTARILY. SLIDING THE RATCHET LOCK TO THE LEFT POSITION DEFEATS THE RATCHET, OPENING THE JAW TO THE OPEN POSITION. THIS WAS REPEATED SEVERAL TIMES TO TRY AND REPLICATE WHAT THE CUSTOMER WAS EXPERIENCING AND THE DEVICE WAS ABLE TO OPEN THE JAW AND CLOSE TO SECURE JAW TIGHT WITHOUT AND ISSUES. AS THE DEVICE WAS RETURNED TO CAREFUSION WITH MOVING PARTS THAT WERE DRY AND REQUIRED LUBRICATION, CAREFUSION REFURBISHED AND LUBRICATED IT PER IFU (INSTRUCTIONS FOR USE) (B)(4) REV D. PER THE IFU, ¿BEFORE STERILIZATION, LUBRICATE THE DEVICE WITH INSTRUMENT MILK OR A STEAM PERMEABLE/WATER SOLUBLE LUBRICANT. CHECK FOR SMOOTH ACTION OF ALL MOVING PARTS.¿ NOT HAVING THE DEVICE PROPERLY LUBRICATED COULD HAVE POSSIBLY CONTRIBUTED TO THE REPORTED FAILURE. THERE IS A POSSIBILITY, THE USER DID NOT HAVE THE RATCHET LOCK FULLY DEPRESSED ALL THE WAY TO THE RIGHT AND THE HAW OPENED UP RELEASING THE NEEDLE OR THE USER DEPRESSED THE THUMB BUTTON DOWN OR SLIDE THE RATCHET LOCK TO THE LEFT IN ERROR, OPENING UP THE JAW TO THE OPEN POSITION. CAREFUSION WAS UNABLE TO DUPLICATE WHAT THE CUSTOMER EXPERIENCED. THE DEVICE FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE DEVICE BECOME AVAILABLE, A FOLLOW-UP EMDR WILL BE SENT.

    Description of Event or Problem · 1

    BROKEN THIS INFORMATION WAS RECEIVED THROUGH REPAIRS AT TUCKER FROM THE CUSTOMER. IT WAS REPORTED THAT "  YES, THE PROCEDURE WAS IMPACTED BY LOSING A NEEDLE INSIDE THE PATIENT CREATING A LONGER OR TIME DUE TO XRAYS AND FLUORO TO FIND THE NEEDLE. NO, IT DID NOT APPEAR TO BE NEW. PATIENT WAS UNHARMED EXCEPT FOR UNNECESSARY EXPOSURE TO XRAYS. NO COMPLAINT.  WE JUST WANT THE INSTRUMENT FIXED".: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER (B)(4) 2014. IT WAS REPORTED THAT "THE INSTRUMENT SPRUNG OPEN DURING THE CASE AND THE NEEDLE WAS TEMPORARILY LOST IN THE PATIENT. X-RAYS WERE DONE AND THE NEEDLE WAS RETRIEVED. NO HARM WAS DONE TO THE PATIENT. THIS ISSUE DID CAUSE THE CASE TIME TO BE EXTENDED AS WELL AS THE PATIENT BEING EXPOSED TO THE X-RAYS NECESSARY TO LOCATE THE NEEDLE. YES THE NEEDLE WAS RETRIEVED FROM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396962 DUCKBILL D-TOUCH DISSECTOR 5MM 45CMRATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION SP90-7271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other