BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-FLEX TRIANGULAR RETRACTOR 80MM 5MM

    MDR report key: 2963746 · Received February 15, 2013

    Report

    Report Number
    1038548-2013-00003
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 26, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED. THE DATE CODE HAS BEEN WORN OFF OF THE INSTRUMENT AND CANNOT BE READ. AS A RESULT, TRACEABILITY TO THE LOT CODE CAN NO LONGER BE DETERMINED. THEREFORE, THE MANUFACTURE DATE AND LOT NUMBER OF THE INSTRUMENT IS UNKNOWN. THE PRODUCT CODE HAS BEEN RE-ETCHED ON THE INSTRUMENT BY AN UNKNOWN 3RD PARTY. THE INSTRUMENT WAS VISUALLY EXAMINED AND SHOWS SIGNS OF EXTREME STRESS AND WEAR. IT WAS OBSERVED THAT THE CAP ON THE ROTATION KNOB HAD BEEN REPLACED BY A 3RD PARTY AND IS NOT A CAREFUSION PART. THE CABLE IS BROKEN AND COMPLETELY WRAPPED AROUND THE SCREW INSIDE OF THE HANDLE. ALL SEGMENTS WERE ACCOUNTED FOR AND RETAINED ON THE NITINOL WIRE (WIRE THAT HOLDS THE SEGMENTS). THE BREAK IS CONSISTENT WITH MECHANICAL OVERSTRESS. THIS OVERSTRESS MOST LIKELY OCCURRED DUE TO OVER TIGHTENING THE ACTUATING KNOB. THIS REPEATED OVER TIGHTENING WOULD CAUSE STRESS, WEAR, AND TEAR OF THE CABLE WHICH OVER TIME HAS CAUSED THE FAILURE. THE PROPER USE OF THIS RETRACTOR IS TO TIGHTEN ACTUATING KNOB UNTIL INTENDED SHAPE IS ACHIEVED, ADDITIONAL TIGHTENING WILL NOT IMPROVE DEVICE PERFORMANCE. THE ROOT CAUSE IS OVERSTRESSING OF THE INSTRUMENT DURING USE. SINCE THE LOT NUMBER IS UNKNOWN A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE OVERSTRESSING OF THE INSTRUMENT DURING USE. TRENDING FOR THE REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND MONITORED.

    Description of Event or Problem · 1

    A LIVER RETRACTOR BROKE DURING USE IN A PATIENT. THE PATIENT RECEIVED A SMALL LACERATION FROM THE RETRACTOR. THE RETRACTOR WAS NOT HOLDING TIGHT DURING THE CASE, SO THEY GOT ANOTHER ONE. WHILE TRYING TO REMOVE THE RETRACTOR IT WOULD NOT COMPLETELY FLEX BACK TO THE STRAIGHT POSITION AND IT GOT STUCK IN THE TROCAR.  THEY WERE ABLE TO REMOVE IT WITH THE TROCAR. THE PATIENT WAS HAVING BARIATRIC SURGERY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013:THE LIVER LACERATION WAS TREATED WITH SURGICEL AND NO FURTHER TREATMENT WAS NECESSARY. THE CASE WAS A LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY.  THE CASE WAS COMPLETED AND NO FURTHER PROBLEMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68072 D-FLEX TRIANGULAR RETRACTOR 80MM 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION 89-6110 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other