BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDDY IRRIGATION TIP

    MDR report key: 8621685 · Received May 17, 2019

    Report

    Report Number
    9611053-2019-00140
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    July 10, 2019
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO BROKEN TIPS WERE RETURNED ONLY UNUSED PRODUCT 3 TIPS. TEST OF UNUSED PRODUCT PASSED THE SAFETY AND MECHANICAL TEST. NO FAULT FOUND ON UNUSED INSTRUMENTS.

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THIS REPORT IS FOR THE FIRST DEVICE. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY SIRONA. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT A CUSTOMER REPORTED THAT TWO EDDY IRRIGATION TIPS BROKE DURING USE IN THE SAME PATIENT. THE BROKEN PARTS WERE REMOVED AND TREATMENT CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411870 EDDY IRRIGATION TIP SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING EIC DENTSPLY VDW GMBH NA 244108

    Patients

    Seq Age Sex Outcome Treatment
    1