BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL ACCESS SHEATH, 11-13 FR X 50CM

    MDR report key: 21861810 · Received April 17, 2025

    Report

    Report Number
    2020550-2025-00654
    Event Type
    Injury
    Date Received
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    WELL LEAD MEDICAL CO., LTD
    Product Code
    FED
    UDI-DI
    06936881196270
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE URETERAL ACCESS SHEATH USED WAS NOT A KARL STORZ PRODUCT. WE HAVE INFORMED (B)(4) OF THIS INCIDENT AS THEY ARE THE MANUFACTURER FOR THE URETERAL ACCESS SHEATH. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE SHEATH DID CAUSE INJURY TO THE PATIENTS URETER AND ENDED UP PERFORATING IT AND IT COULD BE THAT THE SURGEONS TRIED TO PUSH TOO HARD INTO THE KIDNEY AND IT COULD HAVE BEEN THE REASON FOR THE TEAR . A FURTHER EVALUATION CANNOT BE CONDUCTED AS KARL STORZ IS NOT THE LEGAL MANUFACTURER OF THE DEVICE. THE KARL STORZ TEAM DID NOTIFY THE THIRD PARTY DISTRIBUTOR (B)(4) OF THE EVENT REPORT REQUIRED ON APRIL 1,2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733301 URETERAL ACCESS SHEATH, 11-13 FR X 50CM URETERAL ACCESS SHEATH, 11-13 FR X 50CM FED WELL LEAD MEDICAL CO., LTD XUSM0093 08022717BG 06936881196270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other