BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE TWO-PART TROCAR NEEDLE

    MDR report key: 8179031 · Received December 19, 2018

    Report

    Report Number
    1820334-2018-03684
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 4, 2018
    Report Date
    January 7, 2019
    Manufacturer
    COOK INC
    Product Code
    FBQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION THE DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. THE LOT NUMBER IS UNKNOWN SO A SEARCH FOR NON CONFORMANCES COULD NOT BE CARRIED OUT. THE LOT NUMBER IS UNKNOWN SO A SEARCH FOR ADDITIONAL COMPLAINTS COULD NOT BE CARRIED OUT. A REVIEW OF QUALITY CONTROL DATA, MANUFACTURING INSTRUCTIONS, REVIEW OF DRAWING, AND REVIEW OF SPECIFICATIONS WAS CONDUCTED. NO COMPLAINT PRODUCT AND PHOTO HAVE BEEN RETURNED FOR ASSESSMENT AND PHYSICAL EVALUATION. WITH THE AVAILABLE INFORMATION THE CONCLUSION OF THIS COMPLAINT IS THAT A CAUSE COULD NOT BE ESTABLISHED. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6)2018.

    Additional Manufacturer Narrative · 1

    COMMON NAME: TROCAR, GASTRO-UROLOGY. PRO-CODE: FBQ. PMA/510K #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING UNSPECIFIED PROCEDURE(S) USING DISPOSABLE TWO-PART TROCAR NEEDLES, THE INNER STYLET DRAGS AND MAKES AN AUDIBLE GRINDING SOUND AS ITS PASSING THROUGH THE DEVICE. ON AN UNKNOWN NUMBER OF OCCASIONS, IT IS REPORTED THAT THE "DEVICE IS SHEARING COATING OFF WIRES AS IT'S PASSING THROUGH". IT IS UNKNOWN IF THERE HAVE BEEN ANY PATIENT ADVERSE EFFECTS AS A RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017062 DISPOSABLE TWO-PART TROCAR NEEDLE FBQ COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1