BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX RETRACTOR BIG D 120MM 45CM

    MDR report key: 6472932 · Received April 7, 2017

    Report

    Report Number
    1038548-2017-00111
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 24, 2017
    Report Date
    June 26, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ON 30MAR2017, WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED. IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE 89-6216 SNOWDEN PENCER D-FLEX LIVER RETRACTOR DEVICE WAS RECEIVED FOR EVALUATION ON JUNE 9, 2017. EVALUATION OF THE DEVICE BY THE PRODUCT ENGINEER AND THE QUALITY ENGINEER CONFIRMED THE REPORTED ISSUE. VISUAL EXAMINATION REVEALED THAT THE DEVICE WAS RETURNED WITH THE CABLE BROKEN AND STICKING OUT OF THE RETRACTOR. THE PROTECTIVE SLEEVE WAS NOT RETURNED WITH THE DEVICE. THE END OF THE BROKEN CABLE WAS FRAYED AT THE POINT OF THE BREAK WHICH IS INDICATION OF A TENSION BREAK. ALL SEGMENTS WERE ACCOUNTED FOR AND RETAINED ON THE NITINOL WIRE (WIRE THAT HOLDS THE SEGMENTS). IT IS UNKNOWN EXACTLY HOW THE CABLE BROKE BUT THIS BREAK IS INDICATIVE OF SOME TYPE OF EXCESSIVE FORCE/STRESS APPLIED TO THE DEVICE. AS STATED BEFORE THE NITINOL WIRE WAS INTACT HOLDING ALL OF THE SEGMENTS BUT A CLOSER LOOK REVEALED THAT THE WIRE WAS BENT / KINKED AT THE TOP OF THE LARGE TUBE AREA AT THE BEND. THIS IS AN INDICATION THAT THE DEVICE PROTECTIVE SLEEVE WAS MOST LIKELY NOT ALWAYS USED DURING PROCESSING AND STORAGE AS INDICATED IN THE PRODUCTS INSTRUCTION FOR USE, IFU 26-2904. THE DEVICE WAS MOST PROBABLE BEING BENT IN DIFFERENT DIRECTIONS EACH TIME PROCESSED TO FIT IN A PROCESSING TRAY. THE CUSTOMER ALSO INDICATED THAT THE LIVER WAS SLIPPING OFF THE RETRACTOR AND AS A RESULT THE TIGHTENING KNOB WAS TURNED TIGHTER AT WHICH A CERTAIN POINT THE CABLE SNAPPED. THIS TYPE OF OVER TORQUING OF KNOB AND OVERSTRESS / FORCE OF BENDING TO FIT IN A PROCESSING TRAY (WEAKENING THE WIRE AND THE CABLE) COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. CONCLUSION(S): CUSTOMER ¿ MECHANICAL OVERSTRESS. THE DEVICE CABLE BROKE AND FRAYED. THIS BREAK IS INDICATIVE OF SOME TYPE OF EXCESSIVE FORCE/ STRESS APPLIED TO THE DEVICE. IT HAS BEEN RECOMMENDED TO REVIEW THE PRODUCTS INSTRUCTIONS FOR USE, IFU 26-2904, PARTICULARLY THE CAUTION, INSPECTION / MAINTENANCE, AND HANDLING SECTIONS. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA EMAIL: SNOWDEN PENCER D-FLEX LIVER RETRACTOR 89-6216 BROKE DURING A ROBOTIC HERNIA REPAIR CONDUCTED ON FRIDAY, (B)(6) 2017. MORE SPECIFICALLY, THE CABLE SNAPPED AND BROKE OFF INSIDE OF THE PATIENT. A TECH PRESENT IN THE CASE ALSO INDICATED THAT DURING THE CASE, THE LIVER WAS SLIPPING OFF THE RETRACTOR AND AS A RESULT THE TIGHTENING KNOB WAS TURNED TIGHTER AT WHICH A CERTAIN POINT THE CABLE SNAPPED. ALL PIECES OF THE INSTRUMENT WERE RECOVERED FROM THE PATIENT WITH NO ADVERSE EFFECTS. NO PATIENTS OR HCPS WERE AFFECTED BY THE BROKEN INSTRUMENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253942 D-FLEX RETRACTOR BIG D 120MM 45CM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION, INC 89-6216 881722 F16

    Patients

    Seq Age Sex Outcome Treatment
    1