BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX ANGLE TRIANG RETRACTOR 60MM 5MM

    MDR report key: 5806416 · Received July 19, 2016

    Report

    Report Number
    1038548-2016-00089
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 30, 2016
    Report Date
    June 30, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) 89-6111 DEVICE WAS RETURNED FOR EVALUATION FOR STEEL WIRE OF RETRACTOR IS BROKEN. THE CUSTOMER REPORTED, NO PATIENT INJURY OR INTERVENTION, THE PATIENT IS FINE. EVALUATION OF THE DEVICE BY THE QUALITY ENGINEER AND PRODUCT ENGINEER CONFIRMED THE REPORTED ISSUE. VISUAL EXAMINATION REVEALED THAT THE CABLE BROKE AND FRAYED BETWEEN THE 4TH AND 5TH SEGMENT. ALL SEGMENTS WERE ACCOUNTED FOR AND RETAINED ON THE NITINOL WIRE (WIRE THAT HOLDS THE SEGMENTS). IN ADDITION THE BLACK HANDLE WAS OBSERVED TO BE LIGHT GREY WHICH IS INDICATIVE THAT THE DEVICE WAS PROCESSED IN A HIGH ALKALINE CHEMICAL SOLUTION WHICH CAN CAUSE DAMAGE AND WEAKENING OF THE INSTRUMENTS PARTS. THE BREAK IS INDICATIVE OF SOME TYPE OF EXCESSIVE FORCE/ STRESS APPLIED. IT IS UNKNOWN AS TO THE USAGE OF THIS DEVICE AND THEREFORE HOW MANY TIMES IT WAS IMPROPERLY PROCESSED. FORCE/STRESS COUPLED WITH IMPROPER CHEMICAL PROCESSING CAUSE PREMATURE FAILURE OF THE DEVICE. 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 PRODUCTS INSTRUCTIONS FOR USE, IFU 26-2904 REV C, PARTICULARLY THE CAUTION, INSPECTION / MAINTENANCE, CLEANING AND PROCESSING SECTIONS. BD 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

    THE CUSTOMER REPORTED DURING SURGERY, THE STEEL WIRE OF RETRACTOR BROKE WHILE INSIDE THE PATIENT; HOWEVER THERE WAS NO PATIENT INJURY OR INTERVENTION, THE PATIENT WAS FINE. THE LAPAROSCOPIC LIVER RESECTION WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459349 D-FLEX ANGLE TRIANG RETRACTOR 60MM 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION, INC 89-6111 874860

    Patients

    Seq Age Sex Outcome Treatment
    1