BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEESO-ENLARGERS C.A.

    MDR report key: 8035612 · Received November 2, 2018

    Report

    Report Number
    9611053-2018-00175
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Report Date
    December 12, 2018
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED LARGO PEESO REAMER TURNS OUT TO BE BROKEN TWICE, A FIRST TIME AT THE BASE OF THE NECK, A SECOND TIME AT THE BASE OF THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. SUCH A BREAKAGE CASE IS PARTICULAR, THAT WHY WE SUPPOSE THE LARGO HAS BROKEN DURING THE USE A FIST TIME AT THE BASE OF THE NECK PORTION. THE SECOND BREAKAGE PROBABLY OCCURRED DURING THE EXTRACTION OF THE BROKEN OPERATING PART. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. UNUSED REAMERS HAVE BEEN EVALUATED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. 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 IT WAS REPORTED THAT A PESSO ENLARGER WAS BROKEN. THE BROKEN PART WAS REMOVED AND THE CANAL FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875589 PEESO-ENLARGERS C.A. REAMER, PULP CANAL, ENDODONTIC EKP DENTSPLY VDW GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1