BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY HANDPIECE/MODULAR FOR TRS

    MDR report key: 3854327 · Received June 6, 2014

    Report

    Report Number
    2520274-2014-11710
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    N/I
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE MOST LIKELY DUE TO USAGE WEAR OVER TIME. 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 ENGINEERING EVALUATION, IT WAS DISCOVERED THAT THE BATTERY HANDPIECE/MODULAR FOR TRS DEVICE HAD A STICKY TRIGGER. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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
    332885 BATTERY HANDPIECE/MODULAR FOR TRS MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY N/I 003154

    Patients

    Seq Age Sex Outcome Treatment
    1