BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW HANDPIECE.

    MDR report key: 5739764 · Received June 21, 2016

    Report

    Report Number
    1223422-2016-00017
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    April 22, 2016
    Report Date
    June 21, 2016
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR ((B)(4) WAS REPORTED BY THE USER FACILITY TO FDA. PER FDA'S NOTIFICATION, MICROLINE SURGICAL, INC., IS SUBMITTING THIS MDR AS THE MANDATORY REPORTING BY THE MANUFACTURER. THERE WAS NO HARM TO THE PATIENT OR THE OPERATING SURGEON. THE DEVICE WAS RETURNED AND INVESTIGATED BY THE MANUFACTURER. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE ELECTRICAL LEAKAGE TETSING PASSED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT OR THE OPERATING SURGEON.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE OPERATING SURGEON USING A LAPAROSCOPIC HANDPIECE DEVICE, FELT AN ELECTRICAL SENSATION IN THE ARM. THERE WAS NO HARM TO THE PATIENT OR THE OPERATING SURGEON; AND NO ELECTRICAL ARCHING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392584 RENEW HANDPIECE. MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3935 00119424

    Patients

    Seq Age Sex Outcome Treatment
    1 Other