BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR HANDPIECE

    MDR report key: 6175807 · Received December 15, 2016

    Report

    Report Number
    1643264-2016-20007
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    HIH
    PMA / PMN Number
    K031787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER THE CONNECTOR IS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827355 TRUCLEAR HANDPIECE TISSUE REMOVAL SYSTEM HIH SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7209807

    Patients

    Seq Age Sex Outcome Treatment
    1