BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6619597 · Received June 7, 2017

    Report

    Report Number
    9610612-2016-00324
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    October 7, 2016
    Report Date
    June 18, 2020
    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

    B1- MALFUNCTION ONLY, CONFIRMED. B5 - UPDATE. ACCORDING TO THE PROVIDED INFORMATION, THE GD450M HANDPIECE IS NOT RELATED TO THE MENTIONED OVERHEATING. IT SEEMS THAT THE USED DRILL BURR WAS THE REASON FOR THAT. THE DRILL BURR AND HANDPIECE WERE NOT RETURNED TO THE MANUFACTURER. AN INVESTIGATION WAS NOT PERFORMED. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018.

    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

    CLARIFICATION WAS RECEIVED: THE OPERATING ROOM STAFF CONFIRMED THAT THERE WAS NO PATIENT HARM. THE DRILL BURR (UNSPECIFIED PRODUCT) OVERHEATED; THE BURR WAS EXCHANGED. SINCE THE BURR WAS SUSPECTED, THE HANDPIECE WAS NOT CONSIDERED TO BE A COMPLAINED DEVICE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE BURR OVERHEATED AND BURNED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398956 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