BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH SPEED ELEC G1 HANDPIECE AIR COOLED

    MDR report key: 3863923 · Received June 10, 2014

    Report

    Report Number
    1045834-2014-12154
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK133604
    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 SERVICE HOWEVER DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. (B)(4) EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMMERSION DURING CLEANING. 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 SERVICE AND REPAIR PRE-TESTING IT WAS DISCOVERED THAT THE MOTOR DEVICE HAD LIQUID/WATER COMING OUT OF THE DEVICE. THIS EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338997 HIGH SPEED ELEC G1 HANDPIECE AIR COOLED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1