BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/2 SIZE PERF BASKET LID 247X257MM

    MDR report key: 6623169 · Received June 8, 2017

    Report

    Report Number
    9610612-2017-00297
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 14, 2017
    Report Date
    August 14, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    FSM
    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

    BASKETS AND LIDS OPERATED WITHIN SPECIFICATION, AND DID NOT CONTRIBUTE TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404342 1/2 SIZE PERF BASKET LID 247X257MM WIRE BASKETS/TRAYS F.FULL/HALF SIZE FSM AESCULAP AG JF117R

    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