BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRETLER UNIVERSAL URETEROSCOPY STENT SET

    MDR report key: 13577774 · Received February 22, 2022

    Report

    Report Number
    1820334-2022-00277
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 18, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002178137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). PMA/510K #: K181971. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B1, H1: ON RETURN OF DEVICE (B)(6) 2022, THE REPORTED FOREIGN OBJECT WAS IDENTIFIED AS AN O-RING COMPONENT OF THE MALE LUER LOCK ADAPTER. THE MALE LUER LOCK ADAPTER HAD COME APART WITHIN THE WELL OF THE PACKAGING TRAY. THE ADAPTER WAS REASSEMBLED DURING EVALUATION, AND THE O-RING FIT IN ITS INTENDED LOCATION SECURELY WITHIN THE ADAPTER. THERE IS NO EVIDENCE TO SUGGEST THAT THE OBSERVED DEVICE FAILURE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY TOOK PLACE, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED, PRIOR TO THE DISTRIBUTOR DELIVERING A DRETLER UNIVERSAL URETEROSCOPY STENT SET TO THE HOSPITAL, THEY NOTICED A BLACK FOREIGN SUBSTANCE. THE FOREIGN SUBSTANCE APPEARS TO BE A RING. THE DEVICE WAS NOT SENT TO THE HOSPITAL, BUT THEY PLAN TO DELIVER ANOTHER SAME TYPE DEVICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928965 DRETLER UNIVERSAL URETEROSCOPY STENT SET FAD STENT, URETERAL FAD COOK INC G17813 14366643 00827002178137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown