BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY CW4 ARTHROSCOPY PUMP

    MDR report key: 9750634 · Received February 25, 2020

    Report

    Report Number
    1220246-2020-01698
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 25, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE PUMP, JLS-JPUMP, BECOME UNCONTROLLABLE AND THE FLUID WAS FLOWING CONTINUOUSLY. THIS EVENT CAUSED THE PATIENTS LEG TO SWELL. THE SURGEON THEN STOPPED THE PUMP AND CONVERTED TO GRAVITY FLOW. THE CASE WAS COMPLETED BY USING ANOTHER PUMP WITHOUT ANY FURTHER ISSUE. AFTER THE PROCEDURE WAS COMPLETED, AN ECHO TEST WAS PERFORMED ON THE PATIENT AND NO HARM WAS DETECTED. FURTHER INFORMATION REQUESTED. **ADDITIONAL INFORMATION PROVIDED 2/6/20: TWO PERFUSION NEEDLES WERE INSERTED INTO THE THIGHS OF THE PATIENT IN ORDER TO REMOVED THE EXCESS FLUID. THE SURGEON ALSO CONVERTED TO GRAVITY TUBING IN ORDER TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213241 SYNERGY CW4 ARTHROSCOPY PUMP ARTHROSCOPE HRX ARTHREX, INC. SYNERGY CW4 ARTHROSCOPY PUMP 10233682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other