BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LMA STONEBREAKER PNEUMATIC LITHOTRIPTER

    MDR report key: 7784549 · Received August 15, 2018

    Report

    Report Number
    1820334-2018-02521
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    September 8, 2015
    Report Date
    August 15, 2018
    Manufacturer
    COOK INC
    Product Code
    FFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COMMON DEVICE NAME/PROCODE: FFK. (B)(4). THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STONEBREAKER PNEUMATIC LITHOTRIPTER HAD A LEAK IN THE CARTRIDGE DUE TO A FAULTY JOINT, REQUIRING THE PHYSICIAN TO USE OPEN SURGERY TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627902 LMA STONEBREAKER PNEUMATIC LITHOTRIPTER FFK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention