BEUDAMED
    FDA Adverse Event Other Summary report: N

    D-FLEX TRIANGULAR RETRACTOR 80MM 5MM

    MDR report key: 2817584 · Received November 2, 2012

    Report

    Report Number
    1038548-2012-00056
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 4, 2012
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) DEVICE WAS RECEIVED FOR EVALUATION WITH THE REPORTED ISSUE THAT THE INSTRUMENT BROKE WHILE INSIDE A PATIENT AND THE BEADS FROM THE INSTRUMENT WERE RETRIEVED FROM THE PATIENT. THE NUMBER OF BEADS WAS COMPARED TO AN INTACT SNAKE RETRACTOR. AN X-RAY WAS PERFORMED AND THE PATIENT WAS CONSIDERED TO HAVE NO INJURY. VISUAL EXAMINATION OF THE DEVICE RECEIVED CONFIRMED THE REPORTED ISSUE. THE INTERNAL CABLE WAS BROKEN, SLIGHTLY FRAYED AND HELD IN THE JACK SCREW WHICH WAS SEPARATED FROM THE DEVICE. NO SEGMENTS OR NITINOL ROD (WIRE THAT HOLDS THE SEGMENTS) WERE RETURNED WITH THE DEVICE. THE DEVICE WAS AGED AND HAD A DATE CODE OF G02, WHICH MEANS IT WAS MANUFACTURED IN JULY 2002. SINCE THE MANUFACTURING OF THIS PRODUCT IN 2002, THERE HAD BEEN A DESIGN MODIFICATION TO THE NITINOL WIRE IN 2006 IN WHICH THEY LENGTHENED THE WIRE AND ADDED A NIPPLE AT THE END OF THE WIRE TO SECURE THE SEGMENTS IN PLACE REGARDLESS OF THE STATUS OF THE CABLE. IN ADDITION, CUSTOMER LETTERS WENT OUT SEPTEMBER 2012 TO ALL CUSTOMERS PURCHASING INSTRUMENT REINFORCING INSTRUCTIONS FOR USE CLARIFYING IMPORTANCE OF FOLLOWING IFU PROCESSING /STERILIZATION GUIDELINES: CLEAN AND STERILIZE THE INSTRUMENT IN THE COMPLETELY OPENED AND RELAXED POSITION. DO NOT BEND THE LINKS (SEGMENTS) TO FIT THE INSTRUMENT INTO STERILIZATION CONTAINERS AS THIS COULD RESULT IN THE INSTRUMENT BREAKING. DURING STERILIZATION, USE A PROTECTIVE STERILIZING SLEEVE. A DESIGN PROJECT WAS ALSO OPENED MAY 31, 2012 (DESIGN PROJECT # (B)(4)) TO LIMIT THE TENSION OF THE DIAMOND-FLEX RETRACTOR CABLE BY LIMITING ACTUATION OF THE JACK SCREW. LIMITING TENSION IS TO PREVENT OVER-STRESSING THE CABLE WHICH COULD RESULT IN FAILURE. MOST PROBABLE CAUSE IS OVER TIGHTENING DEVICE ACTUATING KNOB CAUSING STRESS, WEAR AND TEAR OVER TIME OF THE CABLE (PREMATURE DEVICE FAILURE). IN ADDITION, THE DEVICE HAS ALSO AGED (MANUFACTURED JULY 2002) AND DID NOT RECEIVE THE DESIGN MODIFICATION OF THE NITINOL WIRE; THEREFORE, ANY MECHANICAL STRESS INCLUDING NOT FOLLOWING PROCESSING/STERILIZATION GUIDELINES COULD HAVE CAUSED THIS FAILURE. OUR RECORDS HAVE BEEN UPDATED TO AID IN ACTIVITIES SHOULD ANOTHER ISSUE BE REPORTED FOR THIS PRODUCT CODE.

    Description of Event or Problem · 1

    THIS COMPLAINT CAME TO US OFF AN MHRA ADVERSE EVENT REPORT FROM (B)(6). NUMBER (B)(4). IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE INSIDE A PATIENT AND THE BEADS FROM THE INSTRUMENT WERE RETRIEVED FROM THE PATIENT. THE NUMBER OF BEADS WAS COMPARED TO AN INTACT SNAKE RETRACTOR. AN X-RAY WAS PERFORMED AND THE PATIENT WAS CONSIDERED TO HAVE NO INJURY. ADDITIONAL INFORMATION RECEIVED (B)(4) 2012: ALL OF THE LINKS WERE DISPOSED OF, SO IT IS THE BODY OF THE DEVICE WHICH IS BEING RETURNED. HOWEVER THE HOSPITAL HAVE CONFIRMED THAT THE PATIENT DID HAVE A X-RAY AND THERE WERE NOT PARTS REMAINING IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-FLEX TRIANGULAR RETRACTOR 80MM 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION 89-6110 771956 OR 772161 G02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other