BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESARA BLUE TVEZ 3.0 SYSTEM

    MDR report key: 20854855 · Received December 5, 2024

    Report

    Report Number
    3003990090-2024-01577
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    May 20, 2024
    Report Date
    November 22, 2024
    Manufacturer
    CALDERA MEDICAL, INC
    Product Code
    PWJ
    UDI-DI
    00890594000124
    PMA / PMN Number
    K211975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    PRIOR TO A SURGICAL PROCEDURE TO IMPLANT A DESARA MESH IN A PATIENT, THE INSTRUMENT WIRE COMPONENT DETACHED FROM ITS HANDLE. THE WIRE BROKE LOOSE, RESULTING IN THE WIRE SPINNING FREELY WITHIN THE HANDLE AND EVENTUALLY COMING OUT COMPLETELY FROM THE HANDLE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WERE REPORTED. BASED ON THE COMPLAINT INFORMATION PROVIDED, IT IS UNCONCLUSIVE IF THE EVENT IS RELATED TO THE DEVICE, SURGICAL APPROACH, SURGEON EXPERIENCE, AND/OR PATIENT ANATOMY. DEVICE HISTORY RECORDS WERE REVIEWED AND DEVICE MET ALL ACCEPTANCE CRITERIA. THIS REPORT IS FILED PURSUANT TO 21 CFR 803 AND ALL INFORMATION CONTAINED WITHIN THIS REPORT IS SUBJECT TO THE DETAILS PROVIDED BY THE REPORTER. ANY SUBSEQUENT INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094591 DESARA BLUE TVEZ 3.0 SYSTEM SUI SLING AND TROCAR PWJ CALDERA MEDICAL, INC CAL-DS01BTV30 P05037 00890594000124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other