BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 11395108 · Received March 1, 2021

    Report

    Report Number
    8010047-2021-03139
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 28, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, INCLUDING A DEVICE HISTORY RECORD (DHR) REVIEW AND A REVIEW OF THE INSTRUCTIONS FOR USE (IFU). PROBABLE CAUSE FOR THE REPORTED EVENT IS DRIED RESIDUE OF LIQUID WHICH REMAINED INSIDE THE TUBE OF THE DETERGENT CHANNEL RESULTED IN A CLOG. AS THE REQUIRED PROCESS FOR LONG TIME STORAGE WAS NOT CONDUCTED, THE TUBE OF DETERGENT CHANNEL CLOGGED. WE CONFIRMED VIA DHR THAT THE SUBJECT EQUIPMENT WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. THE IFU PROVIDES INSTRUCTION FOR LONG TERM STORAGE IN SECTION 7.16 PREPARING THE REPROCESSOR FOR LONG-TERM STORAGE: WHEN THE EQUIPMENT WILL BE STORED FOR MORE THAN 14 DAYS, FOLLOW THE PROCEDURE DESCRIBED IN THIS SECTION.

    Additional Manufacturer Narrative · 1

    AN OLYMPUS REPRESENTATIVE ASSISTED THE CUSTOMER OVER THE PHONE. AFTER ADVISING THE CUSTOMER ON THE TROUBLESHOOTING STEPS AND HOW TO CLEAN THE DETERGENT LINE THE ISSUE WAS RESOLVED. THE OLYMPUS REPRESENTATIVE ALSO ADVISED THE CUSTOMER ON THE PROCEDURES LOCATED IN THE OPERATOR MANUAL FOR LONG TERM STORAGE OF THE DEVICE IF IT IS NOT BEING USED FOR 14 DAYS AND THE PROCEDURE FOR PREPARING THE UNIT FOLLOWING LONG TERM STORAGE. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DETERGENT LINE IN THE ENDOSCOPE REPROCESSOR IS CLOGGED AND THE "DETERGENT REPLACEMENT INDICATOR" WAS BLINKING. AT THE TIME OF THE REPORT THERE WAS NO INDICATOR AND THE CUSTOMER DID NOT KNOW THE ERROR NUMBER. THE CUSTOMER REPORTED THE UNIT HAS NOT BEEN USED SINCE (B)(6) 2021 AND THE TOTAL CYCLE COUNT IS 002291. AS REPORTED, THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. THE CUSTOMER REPORTED THERE WERE NO DEATH, INJURIES, OR INFECTIONS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289665 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1