BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACE URETERAL ACCESS SHEATH

    MDR report key: 18357208 · Received December 19, 2023

    Report

    Report Number
    9610711-2023-00276
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    October 10, 2023
    Report Date
    May 30, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FED
    PMA / PMN Number
    K123675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE SAMPLE RETURNED, WE CANNOT DO MORE THAN DOCUMENTARY INVESTIGATION WHICH REVEALED NO ANOMALY RECORDED DURING PRODUCTION. THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 9090424. CHECKING THE QUALITY DATABASE REVEALED NO ANOMALY IN RELATION TO THE DESCRIBED DEFECT. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER AND SAME DEFECT OVER THE LAST FOUR YEARS: NO SIMILAR CASE WAS FOUND. A RISK MANAGEMENT FRAMEWORK EVALUATION WAS PERFORMED AND CONCLUDED THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE. A CLINICAL ASSESSMENT WAS ALSO PERFORMED AND CONCLUDED THAT THE INCIDENT ¿PROSTATIC TRAUMA WITH HAEMATURIA¿, IS POSSIBLY RELATED TO THE USE OF RETRACE® URETERAL ACCESS SHEATH, HOWEVER, IN THE ABSENCE OF DETAILED INFORMATION ON THE CIRCUMSTANCES OF USE AND WITHOUT THE INCRIMINATED DEVICE WE CANNOT CONCLUDE ON A ROOT CAUSE FOR THIS INCIDENT AND ALTERNATIVE CAUSES ARE POSSIBLE (DEFECTIVE ENDOSCOPE, USE ERROR). CORRECTION: G2 REPORT SOURCE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, IT WAS REPORTED THAT THE SHEATH FAILED (UNSPECIFIED) DURING SURGERY, CAUSING HEMATURIA DUE TO TRAUMA TO THE PATIENT'S PROSTATE. AS REPORTED, THE FLEXIBLE ENDOSCOPE HAD A DEFECT IN THE WORKING CHANNEL. IT IS THEREFORE UNCLEAR WHETHER THE EVENT WAS CAUSED BY THE SHEATH. THE PATIENT REQUIRED POST-OPERATIVE IRRIGATION. THERE IS NO INFORMATION ABOUT THE PATIENT'S CURRENT HEALTH STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459556 RETRACE URETERAL ACCESS SHEATH URETERAL INTRODUCTION SHEATH FED COLOPLAST A/S 9090424_AXXL101002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention