BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.035" HYBRID WIRE, BOX OF 5

    MDR report key: 11733882 · Received April 27, 2021

    Report

    Report Number
    3003790304-2021-00074
    Event Type
    Injury
    Date Received
    April 27, 2021
    Report Date
    June 11, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    EYA
    UDI-DI
    00821925031425
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE INVESTIGATION FINDINGS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. CONCLUSION: THE DEFINITIVE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED DURING AN URETEROSCOPY PROCEDURE USING A HYBRID GUIDEWIRE AND A 22FR RIGID CYSTOSCOPE IN A PATIENT WITH A KIDNEY IMPACTED WITH STONE, THE GUIDEWIRE BROKE INSIDE THE PATIENT WHILE A STENT WAS BEING PLACED. THE PHYSICIAN REPORTS THERE WAS RÉSISTANCE ENCOUNTERED DURING THE CASE BUT IT WAS "NOTHING OUT OF THE ORDINARY". NO LASER OR STONE RETRIEVAL DEVICE WAS USED IN THE CASE. NINE DAYS LATER A SECOND PROCEDURE WAS PERFORMED TO REMOVE THE GUIDEWIRE FRAGMENT AND REMAINING STONE BURDEN. WHEN THE PHYSICIAN GRABBED THE GUIDEWIRE AND IT BROKE INTO EVEN SMALLER PIECES. THERE HAS BEEN NO RENAL IMPAIRMENT OR OTHER ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE RETAINED DEVICE FRAGMENTS. THE PATIENT'S CURRENT CONDITION IS DESCRIBED AS STABLE WITH RESIDUAL DEVICE FRAGMENTS REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628499 0.035" HYBRID WIRE, BOX OF 5 STYLET, URETERAL EYA GYRUS ACMI, INC GWH3505R UNKNOWN 00821925031425

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R