BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM

    MDR report key: 6623183 · Received June 8, 2017

    Report

    Report Number
    9610612-2017-00299
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 14, 2017
    Report Date
    August 14, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: UNITED KINGDOM. IT WAS REPORTED THAT THERE WERE THREE DIFFERENT INCIDENTS WITH THREE DIFFERENT PATIENTS. INCIDENT DETAILS: DURING A DENTAL SURGERY THE DRILL OVERHEATED AND IT BURNED THE INSIDE OF THE PATIENT'S MOUTH. THE DRILL STILL HAS PARTS OF THE SOFT TISSUE FROM THE PATIENT'S MOUTH. DURING A DENTAL SURGERY THE HAND PIECE STARTED SMOKING, THE HAND PIECE WAS CHANGED AND THE SURGERY WAS ABLE TO BE COMPLETED. DURING A DENTAL SURGERY THE OIL INSIDE THE DRILL STARTED LEAKING INSIDE THE PATIENT'S MOUTH. NO HARM TO THE PATIENT. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00296, 9610612-2017-00297, 9610612-2017-00298. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM (X3). GD678 / MICROSPEED UNI MICRO 150 MOTOR (X3). GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. (X3).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE HANDPIECE WAS MANUFACTURED AND DELIVERED IN 2013, ACCORDING TO THE LASER MARKINGS. NO REPAIRS HAVE BEEN EXECUTED IN THE PAST. A FUNCTIONAL TEST WAS HARDLY POSSIBLE. THE BALL BEARINGS ARE RUNNING VERY ROUGHLY AND LOUDLY. THE MILL IS DAMAGED, CORRODED AND STILL STUCK IN THE HANDPIECE AND CAN ONLY BE REMOVED WITH A LOT OF EFFORT. DAMAGES, CORROSION AND RUST CAN BE FOUND AT THE SURFACE OF THE TIP. THE BALL BEARING INSIDE THE TIP IS BROKEN AND CORRODED. FURTHERMORE STAINING AND RUST CAN BE FOUND AT THE INTERIOR AND AT THE COLLET AS WELL. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN OVERLOAD USE AND TO AN INSUFFICIENT MAINTENANCE OF THE DEVICES. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404698 MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM HIGH SPEED POWER SYSTEMS HWE AESCULAP AG GD450M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GD450MM / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL.| GD678 / MICROSPEED UNI MICRO 150 MOTOR