BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSONIC

    MDR report key: 7808551 · Received August 23, 2018

    Report

    Report Number
    2416455-2018-08234
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    May 14, 2018
    Report Date
    September 10, 2018
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    ELC
    UDI-DI
    D661US1030KOS0
    PMA / PMN Number
    K983727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TIP OF THE INSET HAS BROKEN OFF, THIS MAY BE DUE TO A MANUFACTURING DEFECT DURING MANUFACTURING, OR IT COULD BE A DEFECT IN THE MATERIAL FROM AN OUTSIDE SUPPLIER. THERE IS ALSO THE POSSIBILITY OF CUSTOMER ABUSE, THE INSERT MAY HAVE BEEN USED AS A PICK TO REMOVE MATERIAL. (B)(4). LOW POWER UNIT: LOW POWER SETTING: 8.4W, 29,009HZ. HIGH POWER SETTING 31.4W, 29,025HZ. HIGH POWER UNIT: LOW POWER SETTING: 17.7W, 29,078HZ. HIGH POWER SETTING: 31.7W, 29,073HZ. SPRAY, GOOD AT HOW POWER ONLY. SOLDER JOINT, 3/16". TASK FOR (B)(4): QUALITY DEPARTMENT: STATUS: TASK COMPLETED; FOLLOW-UP ACTION COMPLETED. REVIEW COMPLAINT. 06/23/2018 21:03:41 CET (B)(4), RISK IS NEGLIGIBLE, NO CAPA REQUIRED. RISK/CAPA ASSESSMENT: 09/07/2018 15:52:48 CET (B)(4) COMPLAINT HISTORY WAS REVIEWED IN SAP. THE PART WAS MANUFACTURED IN JANUARY 2018. THIS COMPLAINT IS THE ONLY INSTANCE OF A TIP BREAKING FOR THIS PART NUMBER BETWEEN JANUARY 2017 AND JANUARY 2018. RISK ASSESSMENT: PROBABILITY: REMOTE. SEVERITY: MINOR. RISK: MINIMAL. CAPA REQUIRED: NO (ISOLATED INCIDENT TO ONE CUSTOMER).

    Description of Event or Problem · 1

    SCALER TIP BROKE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652335 BIOSONIC ULTRASONIC SCALER TIP ELC COLTENE WHALEDENT INC. US1030KOS D661US1030KOS0

    Patients

    Seq Age Sex Outcome Treatment
    1