BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 15549696 · Received October 6, 2022

    Report

    Report Number
    9610595-2022-02652
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Report Date
    December 12, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT CODE GCQ WAS CHOSEN AS A FIELD REQUIREMENT, HOWEVER, THE TYPE OF SCOPE IS UNKNOWN. IN SPEAKING WITH OLYMPUS TECHNICAL SUPPORT VIA THE PHONE, THE ENDOSCOPY SUPPORT SPECIALIST (ESS) STATED A CALL WAS RECEIVED FROM A FORMER EMPLOYEE. THE CHARGE NURSE WHO HAD REPORTED THE ISSUE, HAD JUST LEFT THE JOB DUE TO BEING UNCOMFORTABLE WITH NO ONE CORRECTING THE DELAYED REPROCESSING ISSUE AND WAS TOLD BY THE PEOPLE IN CHARGE NOT TO WORRY ABOUT IT AND DID NOT GET ANY SUPPORT FROM THE CENTRAL NURSING DIVISION. THE FORMER EMPLOYEE HAD ADVISED MANAGEMENT AT THE FACILITY ABOUT NOT BEING COMPLIANT. THE MANAGEMENT TEAM CHOSE TO CONTINUE TO DO THINGS WRONG WHICH IS WHY THE EMPLOYEE HAD QUIT. THERE WAS NO MENTION OF PATIENT INJURY, DEATH, OR INFECTION. THIS WAS AN ONGOING PROBLEM AND THE ESS STATED THAT ALL THE SCOPES AT THE FACILITY WERE PROBABLY AFFECTED. THE ESS HAD RECENTLY PERFORMED AN ON-SITE TRAINING AND THE STEPS FOR REPROCESSING WERE UNDERSTOOD BY THE TEAM. THE ESS EMPHASIZED WITH THE TEAM THAT THE SCOPES NEED TO BE REPROCESSED RIGHT AFTER THE PROCEDURE AND NOT WAIT UNTIL THE NEXT DAY. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE SCOPES WERE INCORRECTLY REPROCESSED DUE TO NOT FOLLOWING THE REPROCESSING PROCEDURE IN ACCORDANCE TO THE INSTRUCTION MANUAL. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿AN INSUFFICIENTLY CLEANED, DISINFECTED OR STERILIZED ENDOSCOPE AND/OR ACCESSORIES MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO CONTACT THEM.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, AN UNKNOWN AMOUNT OF UNKNOWN OLYMPUS SCOPES WERE BEING REPROCESSED INCORRECTLY. A FORMER EMPLOYEE AT THE FACILITY STATED THE FACILITY WAS INCORRECTLY REPROCESSING ALL SCOPES DELIBERATELY. THE SCOPES WERE BEING LEFT OVERNIGHT AND WASHED THE NEXT DAY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888151 UNKNOWN UNKNOWN GCQ AIZU OLYMPUS CO., LTD. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown