BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 9340601 · Received November 19, 2019

    Report

    Report Number
    1045254-2019-00600
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 11, 2019
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1845020, SERIAL/LOT #: (B)(4), UDI#:(B)(4); PRODUCT ID: 1845020, SERIAL/LOT #: (B)(4), UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 1845000 (S/N: (B)(4)) ANALYSIS FOUND THAT THERE WAS NO PROBLEM WITH THE DRILL. 1845020 (S/N: (B)(4)) ANALYSIS FOUND THAT A BUR CANNOT BE INSERTED INTO THIS ATTACHMENT. 1845020 (S/N: (B)(4)) ANALYSIS FOUND THAT A BUR CANNOT BE INSERTED INTO THIS ATTACHMENT AND ALSO THE BUR CANNOT BE LOCKED. DEVICE AVAILABLE FOR EVALUATION: THE DEVICE EVALUATION AVAILABLE WAS POPULATED TO 'YES' AGAIN FOR VALIDATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BUR CANNOT BE IMMOBILIZED AND IT WAS UNSTABLE DURING USE. THE BUR WAS VIBRATING AND WOBBLY. THERE WAS NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 1

    ON FOLLOW UP, IT WAS STATED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138465 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 212583249

    Patients

    Seq Age Sex Outcome Treatment
    1