BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BIOPSY VALVE (STERILE)

    MDR report key: 6642190 · Received June 14, 2017

    Report

    Report Number
    2951238-2017-00409
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 25, 2017
    Report Date
    March 28, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    PK051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM KNW TO FDS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE INSTRUCTION MANUAL WARNS USERS "INSPECT THE VALVE¿S SLIT AND/OR HOLE FOR DAMAGE. OTHERWISE, PIECES OF IT COULD FALL OFF. INSPECT THE BIOPSY VALVE FOR CRACKS OR OTHER DAMAGE."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE, THE INNER PORTION OF THE BIOPSY VALVE BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON MADE SEVERAL UNSUCCESSFULLY ATTEMPTS TO RETRIEVE THE DEVICE FRAGMENT. THE USER FACILITY REPORTED THAT PRIOR TO THE BREAKAGE AN ENDOSCOPIC SUTURING INSTRUMENT WAS PASSED THROUGH THE BIOPSY VALVE. IT WAS REPORTED THAT THE SURGEON EXPECTS THE PATIENT TO EXCRETE THE VALVE NATURALLY. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED IT WAS UNKNOWN IF THE VALVE WAS INSPECTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422169 SINGLE USE BIOPSY VALVE (STERILE) BIOPSY VALVE FDS OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1555 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1