BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIDWEST ENERGO 1:5

    MDR report key: 24964054 · Received April 23, 2026

    Report

    Report Number
    9614977-2026-00014
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Report Date
    April 28, 2026
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Product Code
    EFB
    UDI-DI
    E27668197960
    PMA / PMN Number
    K972436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT WE HAVE BECOME AWARE OF A MIDWEST ENERGO 1:5 DENTAL HANDPIECE CATALOG # 875315 SERIAL # (B)(6) THAT HAS OVERHEATED AND NO INJURY OCCURRED FROM THE ALLEGED EVENT. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SERIAL NUMBERS INCLUDED IN THIS REPORT: (B)(6). 17 OF 17 DEVICES WERE RETURNED FOR EVALUATION. EVALUATION OF FIVE DEVICES FOUND EXCESSIVE WEAR DUE TO A LACK OF PROPER MAINTENANCE. THE DEVICES DID NOT HEAT UP DURING EVALUATION. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS. EVALUATION OF ONE DEVICE FOUND EXCESSIVE WEAR DUE TO A LACK OF PROPER MAINTENANCE. THIS DEVICE HAD A DEFORMATION ISSUE (DENT). THE DEVICE DID NOT HEAT UP DURING EVALUATION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER EVALUATION OF TWO DEVICES FOUND EXCESSIVE WEAR DUE TO A LACK OF PROPER MAINTENANCE. A FRICTION PROBLEM WAS IDENTIFIED FROM PRESSURE ON THE CAP. THE DEVICES DID NOT HEAT UP DURING EVALUATION. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS. EVALUATION OF FIVE DEVICES FOUND EXCESSIVE WEAR DUE TO A LACK OF PROPER MAINTENANCE. THE DEVICES DID HEAT UP DURING EVALUATION. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS. EVALUATION OF TWO DEVICES FOUND EXCESSIVE WEAR DUE TO A LACK OF PROPER MAINTENANCE. A FRICTION PROBLEM WAS IDENTIFIED FROM PRESSURE ON THE CAP. THE DEVICES DID HEAT UP DURING EVALUATION. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS. EVALUATION OF TWO DEVICES FOUND EXCESSIVE WEAR DUE TO A LACK OF PROPER MAINTENANCE. THE DEVICES HAD DEBRIS BUILD-UP. THE DEVICES DID NOT HEAT UP DURING EVALUATION. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 17 MALFUNCTION EVENTS WHERE MIDWEST ENERGO 1:5 HANDPIECES OVERHEATED. 16 EVENTS RESULTED IN NO INJURY. 1 EVENT RESULTED IN PATIENT BEING SLIGHTLY BURNED WITH NO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499175 MIDWEST ENERGO 1:5 HANDPIECE, AIR-POWERED, DENTAL EFB SIRONA DENTAL SYSTEMS GMBH E27668197960

    Patients

    Seq Age Sex Outcome Treatment
    1