BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION

    MDR report key: 14184467 · Received April 22, 2022

    Report

    Report Number
    9610773-2022-00149
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 22, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020893
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE DEVICE WILL BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. THEREFORE; THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO REDACT REPORT 9610773-2022-00149/MW # (B)(4) AS THIS EVENT WAS PREVIOUSLY REPORTED VIA 9610773-2022-00093/MW # (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CERAMIC TIP FROM THE RESECTION SHEATH, 24 FR INTERMITTENT IRRIGATION BROKE OFF INTRAOPERATIVELY DURING A TRANSURETHRAL RESECTION OF A PROSTATE AND LASER LITHOTRIPSY PROCEDURE. THE FRAGMENT WAS RETRIEVED FROM THE BLADDER. THE ENTIRE PIECE WAS RETRIEVED WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958281 RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION HIH OLYMPUS WINTER & IBE GMBH A22014A AC22028528 04042761020893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown