BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSHIELD BIOSPY VALVE

    MDR report key: 2891027 · Received December 20, 2012

    Report

    Report Number
    1528319-2012-00034
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THERE WAS NO HARM TO PT OR USERS. THE ACTUAL DEVICE INVOLVED WAS NOT RETURNED FOR INVESTIGATION, AND US ENDOSCOPY HAS BEEN UNABLE TO PERFORM TESTING TO CONFIRM THAT A MALFUNCTION OCCURRED. COMPLYING WITH (B)(4) TECHNICAL GUIDELINES REQUIRES THE FACILITY TO PROVIDE, AND WEAR, APPROPRIATE PROTECTIVE EQUIPMENT WOULD ALSO MITIGATE ANY POTENTIAL FOR HARM. REVIEW OF THE LOT HISTORY RECORD INDICATES NO PROBLEMS IN THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE DEVICE COVERS THE OPENING TO THE BIOPSY SUCTION CHANNEL OF AN ENDOSCOPE AND PROVIDES ACCESS FOR DEVICE PASSAGE AND EXCHANGE AND IRRIGATION. THE COMPANY RECEIVED A COMPLAINT THAT DURING SUCTION PORTION OF THE PROCEDURE FLUID/STOOL SPRAYED FORM THE LID OF THE BIOPSY CAP ONTO THE DOCTOR, NURSE AND TECHNICIAN. THERE WAS NO REPORTED HARM TO THE DOCTOR, NURSE, OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSHIELD BIOSPY VALVE IOPSY VALVE KOG UNITED STATES ENDOSCOPY GROUP INC. 711135 79106

    Patients

    Seq Age Sex Outcome Treatment
    1