BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIPORT PLUS 5-11MM WITH FIXATION CANNULA

    MDR report key: 6052106 · Received October 24, 2016

    Report

    Report Number
    9612501-2016-00826
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RECEIVED FOR EVALUATION. DEVICE EVALUATION PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE INSTRUMENT WAS RETURNED WITH THE LENS DISENGAGED. ADHESIVE WAS OBSERVED ON THE LENS AND DISTAL CANNULA TIP WHICH INDICATES THAT THE TWO COMPONENTS HAD BEEN PROPERLY ASSEMBLED. FUNCTIONALLY; WHEN THE TRIGGER WAS ACTUATED, THE KNIFE BLADE ADVANCED AND RETRACTED PROPERLY. PRODUCT ANALYSIS SUGGESTS THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. THE REPORTED CONDITION WAS CONFIRMED. REPLICATION OF THE OBSERVED DAMAGE MAY OCCUR WHEN THE SCOPE IS ADVANCED TOO FAR DOWN THE INNER SHAFT OF THE INSTRUMENT, PAST THE STOP POINT. IN THIS CASE, THE SCOPE IMPACTS THE LENS AND CAUSES THE OBSERVED DAMAGE. THE PRODUCT ANALYSIS CONCLUDED THERE WERE NO DEVICE ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAP VERTICAL SLEEVE GASTRECTOMY, THE TIP CAME OFF OF THE DEVICE WHEN THE SCOPE WAS PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703830 VISIPORT PLUS 5-11MM WITH FIXATION CANNULA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN 176673PF J6D0551X

    Patients

    Seq Age Sex Outcome Treatment
    1