BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSHIELD BIOPSY VALVE

    MDR report key: 3901662 · Received May 6, 2014

    Report

    Report Number
    1528319-2014-00006
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 6, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, THE EXACT ROOT CAUSE OF THE LEAKAGE COULD NOT BE DETERMINED. THE FACILITY REPORTED THAT THE LEAKAGE USUALLY OCCURS AFTER THE PROCEDURE IS COMPLETED DURING HIGH SUCTION CLEANING OF THE SCOPES. THE CUSTOMER STATED THAT THERE WAS NO CONTACT OF FLUID WITH ANYONE AT THE FACILITY. (B)(4) AND ASGE TECHNICAL GUIDELINES REQUIRES THE FACILITY TO PROVIDE, AND WEAR, APPROPRIATE PROTECTIVE EQUIPMENT.

    Description of Event or Problem · 1

    THE BIOSHIELD BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOSHIELD BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE COMPANY RECEIVED A COMPLAINT FROM A USER THAT WHEN HIGH SUCTION WAS USED DURING AND AFTER THE PERFORMANCE OF AN ENDOSCOPIC PROCEDURE, THE CAP OF THE BIOPSY VALVE OPENED AND BIOMATERIAL SPRAYED OUT OF THE OPENING. THE FACILITY REPORTED THAT THERE WAS NO HARM TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271927 BIOSHIELD BIOPSY VALVE BIOPSY VALVE KOG UNITED STATES ENDOSCOPY GROUP, INC. 711135 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1