BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 5880962 · Received August 16, 2016

    Report

    Report Number
    2951238-2016-00690
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    June 29, 2016
    Report Date
    March 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK950636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, AS THE DEVICE IS BEING RETAINED BY THE USER FACILITY¿S RISK MANAGEMENT DEPARTMENT. THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO USER HANDLING. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE WARNS; DO NOT WITHDRAW THE BIOPSY FORCEPS WHILE THE ENDOSCOPE IS ANGULATED. DOING SO COULD CAUSE THE MANIPULATION WIRE TO DETACH FROM THE CUPS. A PART OF MANIPULATION WIRE COULD BE DAMAGED AND DETACHED TO FALL OFF INTO THE PATIENT'S BODY OR THE WIRE MAY STICK OUT AND DAMAGE THE ENDOSCOPE AND/OR CAUSE BLEEDING OR DAMAGE THE MUCOUS MEMBRANE. USING THE EQUIPMENT WITH A DETACHED WIRE COULD CAUSE BLEEDING OR DAMAGE TO THE MUCOUS MEMBRANE.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH ((B)(4)) FORM ON JULY 29, 2016 WHICH REPORTS THAT THE DISPOSABLE BIOPSY FORCEPS BROKE EXPOSING TWO METAL WIRES ON THE DISTAL END ,WHILE OBTAINING A TISSUE SPECIMEN FROM THE PATIENT'S LUNG. IT IS UNKNOWN IF ANY DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532239 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS EOQ OLYMPUS MEDICAL SYSTEMS CORP. FB-211D 58K

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR