BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLPHIN NOSE DISSECTOR TIP REUSABLE

    MDR report key: 6844637 · Received September 6, 2017

    Report

    Report Number
    1223422-2017-00120
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 28, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COPY OF MEDWATCH REPORT MW5071546 WAS RECEIVED BY MICROLINE SURGICAL ON 8/28/2017. THE USER FACILITY NEVER CONTACTED MICROLINE SURGICAL DIRECTLY ABOUT THIS INCIDENT. AT THE TIME OF THE INCIDENT THE REPORTED PRODUCT (3311) WAS UNDER RECALL BY MICROLINE SURGICAL. THE USER FACILITY STATES IN THE MEDWATCH REPORT THAT THEY WERE AWARE OF THE RECALL AND HAD EDUCATED THEIR STAFF ON THE ISSUE. THE DIRECTION IN THE RECALL ANNOUNCEMENT INSTRUCTS USER FACILITIES TO RETURN ALL RELATED PRODUCT AND CONTACT MICROLINE SURGICAL FOR REPLACEMENT OPTIONS. BEING AWARE OF THIS ISSUE, THE USER FACILITY SHOULD NOT HAVE USED THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MICROLINE. THEREFORE NO INVESTIGATION TO CONFIRM THIS FAILURE CAN BE PERFORMED. TESTING HAS BEEN PERFORMED ON THE HEAT SHRINK THAT SHOWS THAT THE INSULATION LIKELY CRACKED AND THEN SHRUNK. IT IS UNLIKELY THAT THE HEAT SHRINK BROKE INTO PIECES AND THAT A PIECE REMAINS IN THE ABDOMEN. WE WILL BE CONTACTING THE USER FACILITY TO SHARE THIS INFORMATION.

    Description of Event or Problem · 1

    FROM MEDWATCH REPORT MW5071546 SUBMITTED BY USER FACILITY: MICROLINE TIP INSERTED THROUGH TROCAR. UPON INSERTION IT WAS NOTED THAT THE INSULATION FELL INTO THE ABDOMEN. WAS IMMEDIATELY RETRIEVED. SEARCHED ABDOMEN AND FIELD FOR 2ND HALF OF INSULATION AND WAS UNABLE TO RETRIEVE. THIS PRODUCT IS CURRENTLY ON VOLUNTARY RECALL THROUGH MICROLINE. ALL EDUCATION TO STAFF WAS DONE PRIOR IN ORDER TO ALERT STAFF OF RECALL AND EDUCATE AS TO HOW TO LOOK CRACK IN INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626240 DOLPHIN NOSE DISSECTOR TIP REUSABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MICROLINE SURGICAL, INC. 3311 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention