BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSII STEREOSCOPIC VISION SYSTEM

    MDR report key: 2656046 · Received June 22, 2012

    Report

    Report Number
    9616637-2012-00001
    Event Type
    Other
    Date Received
    June 22, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    VISIONSENSE, LTD.
    Product Code
    GWG
    PMA / PMN Number
    K081102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED THE DEVICE ON 06/19/2012 FOR INSPECTION AND FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    DURING USE OF VISIONSENSE VSII STEREOSCOPIC ENDOSCOPE, A MICRODEBRIDER TOOL STRUCK THE DISTAL TIP OF THE DEVICE SEVERAL TIMES, RESULTING IN NOTICEABLE SCRATCHES ON FRONT LENS (SURGEON ASSUMED IT WAS "DIRT"). THE ENDOSCOPE WAS PULLED OUT FOR "DIRT" REMOVAL. SURGEON TRIED TO AGGRESSIVELY RUB THE "DIRT" OFF THE TIP. IMMEDIATELY AFTER RE-INSERTION OF ENDOSCOPE, THE CAMERA (LOCATED AT THE TIP OF THE ENDOSCOPE) STOPPED WORKING. APPARENTLY, THE STRIKING OF THE ENDOSCOPE'S TIP LOOSENED THE LENS HOUSING WHICH RESULTED IN A DISLODGED HOUSING DURING AGGRESSIVE MANUAL CLEANING. IT APPEARS THAT THE LENS CAME OFF DURING CLEANING AS THE "DIRT" DISAPPEARED FROM THE IMAGE PRIOR TO INSERTION INTO THE PT. AS A RESULT, WITHOUT THE DISTAL WINDOW, THE CAMERA'S ELECTRONICS BECAME UNPROTECTED, LIQUID PENETRATED THE BORE AND CAUSED THE CAMERA TO STOP WORKING A FEW SECONDS AFTER THE SURGEON RE-USED IT. THE SURGERY WAS ABLE TO BE COMPLETED WITH MINIMAL DELAY BY USING A REPLACEMENT ENDOSCOPE. THE LEN'S STAINLESS STEEL HOUSING OF 3.5MM DIAMETER WITH ITS ENCAPSULATED GLASS LENS COULD NOT BE LOCATED WITHIN THE SURGICAL FIELD OR IN THE DETRITUS THAT WAS SUCTIONED OUT DURING SURGERY, AS OF ITS SMALL SIZE. THE PT HAS BEEN X-RAYED AND THERE WAS NO FOREIGN BODY FOUND (LENS HOUSING IS STAINLESS STEEL AND IS RADIO OPAQUE). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSII STEREOSCOPIC VISION SYSTEM NEUROLOGICAL ENDOSCOPE GWG VISIONSENSE, LTD. 172-0080

    Patients

    Seq Age Sex Outcome Treatment
    1