BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX UNIVERSAL IRRIGATION CONSOLE

    MDR report key: 2762101 · Received September 27, 2012

    Report

    Report Number
    1017294-2012-00044
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN RECEIVED, THE SERVICE TECHNICIAN EVALUATED THE PUMP PER MANUFACTURE'S PROCEDURE, AND WAS UNABLE TO DUPLICATE OR FIND ANY ISSUE THAT WOULD HAVE LED TO THE REPORTED PROBLEM. THE PUMP FUNCTIONED PROPERLY, WITH NO FLUCTUATION IN PRESSURE OR FLOW. HIS DEVICE WAS MANUFACTURED ON 10/03/1995, AND IS 16 YEARS OLD. ALSO, THE LAST DATE OF SERVICE FOR THIS DEVICE WAS ON 04/20/2011. THE PRODUCT MANUAL RECOMMENDS A 12 MONTH PREVENTIVE MAINTENANCE SCHEDULE. THE PRODUCT MANUAL WARNS: DO NOT ALLOW CONTROLLER (PUMP) TO RUN UNATTENDED. PATIENT SAFETY REQUIRES THE IRRIGATION CONTROLLER (PUMP) TO BE CONTINUOUSLY MONITORED DURING OPERATION. SYNOVIAL INJURY MAY WARRANT LOWER INTRA-ARTICULAR PRESSURE AND DISTENTION, AS WELL AS, MORE FREQUENT VISUAL EXAMINATION. ACCURATE CANNULA PLACEMENT IS ESSENTIAL TO AVOID EXTRAVASATION OF FLUIDS. PLACEMENT OF THE CANNULA SHOULD BE VERIFIED TO ENSURE DISTAL END IS WITHIN JOINT CAPSULE. AVOID ABRUPT CHANGES IN JOINT POSITION, WHICH MAY RESULT IN HIGH INTRA-ARTICULAR PRESSURE SPIKES. CLOSELY MONITOR PATIENT DURING AND AFTER OPERATIVE PROCEDURE FOR SIGNS OF COMPLICATIONS RESULTING FROM EXCESS FLUID ABSORPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, AN EXTRAVASATION TOOK PLACE. ACCORDING TO THE SURGEON'S DICTATED OPERATIVE NOTE; "THE SHOULDER BLEW-UP, AND A FASCIOTOMY OF THE DELTOID WAS ACCOMPLISHED". THE SURGEON STATED THAT, HE DID PERFORM A MINOR FASCIOTOMY, BUT DOES NOT CONSIDER IT TO BE OF CONCERN. THE SURGEON ALSO STATED THAT THE PATIENT'S RECOVERY FROM THE PROCEDURE HAS NOT BEEN AFFECTED BY THE FASCIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX UNIVERSAL IRRIGATION CONSOLE ARTHROSCOPE, ORTHOPEDIC HRX CONMED LINVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other ITEM #C7122-APEX 2-CON TUBING SET, NO LOT INFO| ITEM #C7115/SN #(B)(4)-APEX REMOTE HAND CONTROL