BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW HANDPIECE

    MDR report key: 6844613 · Received September 6, 2017

    Report

    Report Number
    1223422-2017-00119
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 10, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED TO MICROLINE INC FOR A PRODUCT INVESTIGATION. WE TRIED MULTIPLE TIMES TO GET MORE INFORMATION FROM THE USER FACILITY AND WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE PATIENT EXPERIENCE A BURNING SENSATION FROM THE RENEW HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626919 RENEW HANDPIECE RENEW LAPAROSCOPIC INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3904 00130357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other