BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 6916313 · Received October 5, 2017

    Report

    Report Number
    2951238-2017-00666
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 14, 2017
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    PK011314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM ITX TO ODG.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) FINDINGS. THE ESS VISITED THE USER FACILITY ON OCTOBER 17, 2017 TO OBSERVE THE STAFF¿S REPROCESSING PRACTICES AND TO PROVIDE A REPROCESSING IN-SERVICE. THE ESS FOUND NO REPROCESSING DEVIATIONS PERFORMED.

    Additional Manufacturer Narrative · 1

    OLYMPUS MADE MULTIPLE FOLLOW UPS WITH THE USER FACILITY BY TELEPHONE AND IN WRITING IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. AS PART OF OUR INVESTIGATION, OLYMPUS PERFORMED AN INSTRUMENT SERVICE HISTORY REVIEW AND FOUND NO INFORMATION ON THE REPORTED SCOPE. IN ADDITION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS REQUESTED TO BE DISPATCHED TO THE USER FACILITY TO OBSERVE THE FACILITY¿S REPROCESSING PRACTICE AND TO PROVIDE A REPROCESSING TRAINING. TO DATE, THE ESS VISIT HAS NOT BEEN FINALIZED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER AN UNSPECIFIED PROCEDURE, THE SCOPE WAS VIEWED UNDER A MICROSCOPE AND FOUND AN UNSPECIFIED BACTERIUM ON THE SCOPE. IT WAS FURTHER REPORTED BY THE USER FACILITY THAT THE SCOPE MAY HAVE BEEN IMPROPERLY REPROCESSED BY NEWLY HIRED STAFF. THE USER FACILITY HAS REQUESTED FOR A REPROCESSING TRAINING IN-SERVICE BY AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS). THERE ARE NO REPORTS OF PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698236 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UC140P-AL5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1