BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MB-358 SEMI-DISPO. BIOPSY VALVE (10PCS)

    MDR report key: 5805368 · Received July 19, 2016

    Report

    Report Number
    2951238-2016-00604
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 30, 2016
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    PK944610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE FACILITY USES A THIRD PARTY REPAIR ENTITY TO REPAIR AND SERVICE THE SCOPE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INSTRUCTION MANUAL WARNS USERS: ¿CONFIRM THAT THE SLIT AND HOLE ON THE BIOPSY VALVE HAVE NO SPLITS, CRACKS, DEFORMATIONS, DISCOLORATION, OR OTHER DAMAGE. THE BIOPSY VALVE IS A CONSUMABLE THAT SHOULD BE INSPECTED AS FOLLOWS BEFORE EACH USE. REPLACE IT WITH A NEW ONE IF ANY IRREGULARITY IS OBSERVED DURING THE INSPECTION. ¿

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A RUBBER PIECE FROM THE SCOPE FELL INTO THE PATIENT. THE SURGICAL STAFF BELIEVED THIS FRAGMENT TO BE THE BIOPSY VALVE. THE DEVICE FRAGMENT WAS RETRIEVED FROM THE PATIENT USING FORCEPS. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460888 MB-358 SEMI-DISPO. BIOPSY VALVE (10PCS) BIOPSY VALVE FDS OLYMPUS MEDICAL SYSTEMS CORP. MB-358 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1