BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX ANGLE TRIANG RETRACTOR 60MM 5MM

    MDR report key: 6171075 · Received December 13, 2016

    Report

    Report Number
    1038548-2016-00100
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 19, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) 89-6111 DEVICE WAS RETURNED FOR EVALUATION. THE PRODUCT ENGINEER, MANUFACTURING ENGINEER AND THE QUALITY ENGINEER CONFIRMED THE REPORTED ISSUE. VISUAL EXAMINATION REVEALED THAT THE END CAP TO THE HANDLE WAS MISSING AND THE CABLE WIRES WERE PROTRUDING OUT OF THE BACK OF THE ROTATION KNOB. THE HANDLE WAS EXTREMELY LOOSE FROM THE LONG EXTENSION TUBE AND TUBE SEEMS TO OVEREXTEND THE POSITIONING WHERE THE FLUSH PORT MEETS. THE CABLE WAS BROKEN (PARTIALLY FRAYED) AND THE NITINOL WIRE WAS OF A BLUISH COLOR AND DIAMETER WHICH WAS NOT OF BD CRAFTSMANSHIP. THE SEGMENTS WERE STILL RETAINED ON THE DEVICE HOWEVER, DUE TO THE SEGMENTS BEING ASSEMBLED IN THE INCORRECT POSITION AND EXCESSIVELY WORN, THE DEVICE WOULD NEVER BE ABLE TO OBTAIN THE ORIGINAL TRIANGULAR SHAPE EVEN IF THE CABLE HAD NOT BEEN BROKEN. LASTLY, THE ETCHING ON THE DEVICE INDICATED THE DEVICE WAS MANUFACTURED IN 1999 (17 YEARS OLD) AND WAS NEVER REPAIRED BY BD. THE DEVICE WAS ONE OF THE OLDEST DESIGNS FOR THIS PRODUCT AND THEREFORE NEVER RECEIVED BD¿S DESIGN IMPROVEMENTS. IN ADDITION, THE ORIGINAL BD ETCHING WAS MISSING AND THERE WAS ETCHING ON THE DEVICE THAT WAS NOT FROM BD. BASED ON THE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED FAILURE IS DUE TO AN IMPROPER THIRD PARTY REPAIR. THE DEVICE IS 17 YEARS OLD, HAS BEEN REPAIRED BY AN UNKNOWN SOURCE AND IS UNREPAIRABLE; THEREFORE, IT HAS REACHED ITS LIFE EXPECTANCY. IT HAS BEEN RECOMMENDED TO REVIEW THE PRODUCT¿S INSTRUCTIONS FOR USE, IFU (B)(4), PARTICULARLY THE INSPECTION/MAINTENANCE, AND REPAIR SECTIONS. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE HANDLE ROTATION SYSTEM IS DAMAGED. NEITHER PATIENT INJURY NOR MEDICAL INTERVENTION HAS BEEN REPORTED. ADDITIONAL INFORMATION, THE CUSTOMER REPORTED, NO RESPONSE, WHEN ASKED IF THE WIRE BROKE, THE DEVICE DID NOT BREAK DURING PATIENT USE OR INSIDE THE PATIENT'S BODY. THE PATIENT WAS NOT INJURED OR REQUIRE MEDICAL INTERVENTION. ON 07DEC2016, AFTER THE DEVICE WAS RECEIVED AT PLANT IT WAS NOTED THE CABLE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820006 D-FLEX ANGLE TRIANG RETRACTOR 60MM 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION, INC 89-6111 F99 AAAA0558

    Patients

    Seq Age Sex Outcome Treatment
    1