BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA

    MDR report key: 3962087 · Received July 28, 2014

    Report

    Report Number
    1045834-2014-12530
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS DISCOVERED THAT THE CONSOLE DEVICE WAS NOT WORKING. THE REPORTER STATED THAT THERE WAS LESS THAN A THIRTY MINUTE DELAY TO THE SURGICAL PROCEDURE. THE AMOUNT OF DELAY WAS NOT SPECIFIED. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437574 SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA MOTOR, DRILL, ELECTRIC - CONSOLE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1