BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6266434 · Received January 20, 2017

    Report

    Report Number
    9610612-2017-00025
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 22, 2016
    Report Date
    December 15, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    HBC
    PMA / PMN Number
    K053526
    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 WHILE IN USE BY THE SURGEON THE DRILL OVER HEATED AND BURNED THE PATIENT'S LIP. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: GD678 / MICROSPEED UNI MICRO 150 MOTOR, GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DEVICE WAS MANUFACTURED IN 2011. A REPAIR STAMP COULD NOT BE FOUND ON THE DEVICE. A FUNCTIONAL TEST HAS BEEN CARRIED OUT. AFTER A SHORT PERIOD OF TIME, THE HANDPIECE GETS HOT. AFTER ONE MINUTE, THE TEMPERATURE IS 50 DEGREES CELSIUS. THE TIP OF THE HANDPIECE IS DAMAGED. TWO BALL BEARINGS INSIDE THE DEVICE ARE BROKEN. THE INTERIOR SHOWS CORROSION AND FRAGMENTS OF THE BROKEN BALL BEARINGS. 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 DEVICE. NO CAPA IS NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THERE WERE THREE DIFFERENT BURNS TO THREE DIFFERENT PATIENT'S LIPS, IT IS UNSURE IF CAUSED BY THE SAME DRILL OR DIFFERENT DRILLS. ON (B)(6) 2016: IT WAS REPORTED THAT DURING SURGERY THE HAND PIECE OVER HEATED AND BURNT THE PATIENT'S LIP (MOTOR SN# (B)(4)) AND THE BURR COULD NOT BE REMOVED. ON (B)(6) 2016: IT WAS REPORTED THAT THE HAND PIECE OVER HEATED AND BURNT THE PATIENT'S LIP (MOTOR SN# (B)(4) AND HEADPIECE SN# (B)(4)). (B)(6): (THERE WAS NO SPECIFIC DATE PROVIDED FOR THIS COMPLAINT OTHER THAN THE MONTH OF (B)(6)). IT WAS REPORTED THAT THE DEVICE BURNT THE PATIENT'S LIP AT THE BEGINNING OF THE PROCEDURE. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM / SN# (B)(4). GD678 / MICROSPEED UNI MICRO 150 MOTOR / SN# (B)(4). GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. / SN# (B)(4). GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM / SN# (B)(4). GD678 / MICROSPEED UNI MICRO 150 MOTOR / SN# (B)(4). GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. / SN# (B)(4). GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM / SN# (B)(4). GD672 / MICROSPEED UNI MICRO 150 MOTOR / SN# (B)(4). GD678 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. / SN# (B)(4). ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00025, 9610612-2017-00026, 9610612-2017-00027. INFORMATION WAS NOT REPORTED OF THE PARTICULAR DEVICES USED DURING EACH OCCURRENCE. AS THIS INFORMATION HAS NOT YET BEEN RECEIVED, THREE MED WATCH REPORTS ARE BEING SUBMITTED CONTAINING ALL KNOWN INFORMATION, WHEN ADDITIONAL INFORMATION IS RECEIVED FOLLOW UP INFORMATION WILL BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49297 MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM HIGH SPEED POWER SYSTEMS HBC AESCULAP AG GD450M 11-1003463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F / 2.35X70M| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD672 / MICROSPEED UNI MICRO 150 MOTOR / SN#(B)(4)| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. /| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. /| GD678 / MICROSPEED UNI MICRO 150 MOTOR| GD678 / MICROSPEED UNI MICRO 150 MOTOR / SN#(B)(4)| GD678 / MICROSPEED UNI MICRO 150 MOTOR /SN#(B)(4)| GD678 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. /| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F / 2.35X70M| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM| GD672 / MICROSPEED UNI MICRO 150 MOTOR / SN#(B)(4)| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. /| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. /| GD678 / MICROSPEED UNI MICRO 150 MOTOR| GD678 / MICROSPEED UNI MICRO 150 MOTOR / SN#(B)(4)| GD678 / MICROSPEED UNI MICRO 150 MOTOR /SN#(B)(4)| GD678 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. /