BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INSTRUMENT WIPE (48/PK)

    MDR report key: 10312337 · Received July 23, 2020

    Report

    Report Number
    1037007-2020-00025
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Report Date
    July 22, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    NAB
    PMA / PMN Number
    EXEMPT-NAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. THE USER LIKELY DISPOSED OF THE SUBJECT WIPE AND/OR NO LONGER IN USERS¿ POSSESSION. BASED ON THE REPORTED EVENTS AND INFORMATION GATHERED FROM THE REPORTER AND OLYMPUS REPRESENTATIVE, THE REPORTED ISSUE WAS DUE TO OFF LABEL USE. THERE IS NO DEDICATED INSTRUCTIONS FOR USE FOR THE MICRO INSTRUMENT WIPES, HOWEVER THE LABELING DOES DESCRIBE THAT IT IS AN INSTRUMENT WIPE. IT IS NOT DESCRIBED AS MEANT TO BE INSERTED INTO A PATIENT. TO DATE, NO PATIENT HARM OR INJURY WAS REPORTED. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MIDDLE EAR PROCEDURE AS DESCRIBED BY THE REPORTER, THE CUSTOMER USED THE 230030 MICRO WIPE IN AN OFF LABEL MANNER. ACCORDING TO THE REPORT, THE USER CUT THE WIPE AND USED AS A BACKGROUND FOR THE SCOPE TO POINT AT INSIDE THE PATIENT HOWEVER, THE USER LOST THE PIECE OF 230030 INSIDE THE PATIENT. THE USER CALLED THE OLYMPUS REPRESENTATIVE AND INQUIRED IF THE PIECE IS A RADIO OPAQUE AS THE USER TRIED TO LOCATE THE PIECE OF WIPE IN THE PATIENT. THE OLYMPUS REPRESENTATIVE CONFIRMED TO THE USER THAT THE WIPE (PIECE OF WIPE) IS NOT RADIOPAQUE. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782406 MICRO INSTRUMENT WIPE (48/PK) MICRO INSTRUMENT WIPE NAB GYRUS ACMI, INC 230030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1