BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX TRIANGULAR RETRACTOR 80MM ANG 5MM

    MDR report key: 5034812 · Received August 27, 2015

    Report

    Report Number
    1038548-2015-00068
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 5, 2015
    Report Date
    October 27, 2015
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE 89-6112 D-FLEX TRIANGULAR RETRACTOR WAS NOT RECEIVED FOR EVALUATION BUT A PHOTO OF THE INSTRUMENT WAS PROVIDED. BASED ON THE PHOTO A DATE CODE WAS PROVIDED; THEREFORE, A DHR REVIEW COULD BE PERFORMED. ACCORDING TO THE SALES REP THE DEVICE WILL BE RETURNED FOR EVALUATION BUT THE FACILITY INVESTIGATION WILL TAKE A LONG TIME; THEREFORE, BASED ON THIS INFORMATION, PHOTO AND INFORMATION PROVIDED ALREADY BY THE CUSTOMER, THE EVALUATION WILL BE PERFORMED WITHOUT THE DEVICE. THIS COMPLAINT WILL BE RE-OPENED AND UPDATED ONCE THE DEVICE IS RETURNED. ALTHOUGH THE DEVICE WAS NOT RECEIVED FOR EVALUATION, FROM THE DESCRIPTION OF THE REPORTED INCIDENT IT IS LIKELY THAT THE JACK SCREW HAD ALREADY RETURNED TO THE POSITION WHERE THE INSTRUMENT WOULD BE RELAXED, WHICH IS WHY THE KNOB WOULDN¿T TURN SINCE IT WOULD COME TO A HARD STOP. A PROBABLE REASON THAT COULD CAUSE A CASE LIKE THIS WOULD BE A FRAYED CABLE WHICH WOULD CAUSE THE STRANDS TO STICK OUT AND CATCH ON THE EDGE OF ONE OF THE SEGMENTS. THIS FAILURE OF THE CABLE HAS BEEN PREVIOUSLY IDENTIFIED AND A PROJECT WAS INITIATED 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. THE NEW DESIGN WAS IMPLEMENTED IN FEBRUARY 2014. THIS DEVICE WAS CONFIRMED TO BE MANUFACTURED PRIOR TO THE DESIGN IMPLEMENTATION. OVERSTRESSING THE DEVICE CAN STILL OCCUR WHEN ENOUGH FORCE AND STRESS HAS BEEN APPLIED TO THE DEVICE IN THE SEGMENTED AREA WHICH CAN CAUSE CABLES TO BREAK. NOT USING THE PROTECTIVE SLEEVE DURING STORAGE AND STERILIZATION CAN ALSO CAUSE THE CABLE TO WEAR PREMATURELY AND BREAK. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. IT HAS BEEN RECOMMENDED TO REVIEW THE PRODUCT INFORMATION FOR THIS DEVICE, IFU 26-2904 REV C, PARTICULARLY THE CARE, STORAGE, INSPECTION AND MAINTENANCE SECTION. CAREFUSION WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Additional Manufacturer Narrative · 1

    (B)(4): IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SALES REP STATED, THE LIVER RETRACTOR, 89-6110, WAS IN A PATIENT AND ENGAGED. AT THE END OF THE PROCEDURE, THE RETRACTOR WOULD NOT DISENGAGE AND RELEASE THE TENSION. THE KNOB WOULD NOT TURN. I WAS CALLED AND WAS PRESENT. AFTER SEVERAL ATTEMPTS TO RELEASE THE TENSION, WE DECIDED TO CUT THE RETRACTOR.ࠉN FEAR OF THE RETRACTOR BREAKING INTO SEVERAL PIECES, I SUGGESTED USING A GRASPER TO PULL THE END OF THE RETRACTOR IN HOPE IT WOULD RELEASE.ࠉT DID.ࠁND THE TENSION KNOB REENGAGED. THE PATIENT WAS UNDER ANESTHESIA AN EXTRA 30 MINUTES DUE TO THE INSTRUMENT FAILURE. THE INSTRUMENT IS BEING QUARANTINED AT THE FACILITY AND IT IS CURRENTLY BEING INVESTIGATED BY THEIR RISK MANAGEMENT DEPARTMENT. ADDITIONAL INFORMATION RECEIVED 26AUG2015: THE SALES REP REPORTED: THE FACILITY DEPARTMENT OF THE REPORTING EVENT IS THE BARIATRIC DEPT. THE BARIATRIC PROCEDURE WAS DELAYED AND THE PATIENT WAS SEDATED 45 MINUTES LONGER DUE TO INSTRUMENT FAILURE. THERE WAS NO PATIENT INJURY. THERE WAS NO RETAINED PIECES IN THE PATIENT'S BODY. NO MENTION IF A DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED 26AUG2015: THE CUSTOMER REPORTED, THE INSTRUMENT (BARIATRIC LIVER RETRACTOR WAS BEING USED DURING A CASE (RETRACTING A LIVER) AND AT THE END OF THE CASE IT WOULD NOT DISIN-GAGE (GO BACK TO STRAIGHT AND FLEXIBLE )TO REMOVE IT FROM THE BODY THROUGH THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570369 D-FLEX TRIANGULAR RETRACTOR 80MM ANG 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION 89-6112 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1