BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE

    MDR report key: 2231230 · Received September 1, 2011

    Report

    Report Number
    1220246-2011-00138
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K083707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. PRIOR TO THE CLAIM OF OVERPRESSURE IN THE JOINT AND PATIENT INJURY THE PUMP WAS TESTED AND RETURNED TO THE CUSTOMER. EVALUATION OF THE PUMP DID NOT CONFIRM THE CLAIM OF OVERPRESSURE. NO FURTHER INFORMATION WAS GIVEN ON THE NATURE OF THE INJURY AFTER SEVERAL ATTEMPTS TO GET AN UPDATE. REVIEW OF SIMILAR EVENTS REPORTED TO ARTHREX, WHERE PUMP AND TUBING WERE RETURNED FOR EVALUATION, INDICATE THAT OR PROCEDURES RELATED TO THE SET-UP OF THE DEVICE AND TUBING DID NOT CONFORM TO INSTRUCTIONS PROVIDED. THE LABELING FOR THE DEVICE AND ASSOCIATED TUBING, INSTRUCTION MANUAL FOR THE PUMP AND TROUBLESHOOTING GUIDE FOR THE DEVICE CLEARLY OUTLINE THE PROPER SET-UP PROCEDURE AND SUFFICIENTLY WARN THE USER OF THE POTENTIAL CONSEQUENCES (EXTRAVASATION) IF INSTRUCTIONS FOR USE ARE NOT FOLLOWED. THE INSTRUCTIONS FOR USE FOR BOTH THE PUMP AND TUBING SETS CLEARLY WARN THE USER OF THE CONSEQUENCES OF NOT FOLLOWING THE INSTRUCTIONS FOR USE. ON THE PACKAGE, THERE IS A LABEL INSTRUCTING THE USER AS FOLLOWS: WARNING: DO NOT RECONNECT TUBING FOR ANY REASON. RECONNECTING TUBING THAT WAS DISCONNECTED MAY CAUSE PUMP PRESSURE MONITORING SYSTEM ERRORS WHICH MAY CAUSE EXTRAVASATION THAT COULD RESULT IN SERIOUS PATIENT INJURY. IN ADDITION TO EQUIPMENT SET-UP, THE OPERATIVE JOINT CAPSULE MAY HAVE ALREADY BEEN COMPROMISED FROM PRIOR (PREOPERATIVE) INJURY OR TRAUMA. ALSO, INCORRECT PRESSURE SETTINGS OR INTER-OPERATIVE COMPROMISING OF THE JOINT CAPSULE FROM OTHER INSTRUMENTATION COULD LEAD TO SUCH AN EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERPRESSURE IN THE JOINT OF THE PATIENT WHICH CAUSED AN INJURY. NO FURTHER INFORMATION OR UPDATE GIVEN ON THE NATURE OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHROSCOPE HRX ARTHREX, INC. NX1070NH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other