BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS

    MDR report key: 16030577 · Received December 21, 2022

    Report

    Report Number
    9614641-2022-00831
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 21, 2022
    Report Date
    February 11, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    14953170029773
    PMA / PMN Number
    K962555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT AND THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM AN OLYMPUS REPRESENTATIVE AS REPORTED ON B5 AND BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION AND THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DATE OF THE EVENT AND LOT NUMBER WAS UNKNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR 1ZK~2YK FOR OVER THE PAST YEAR PRIOR TO THE DATE OF OCCURRENCE WAS INSPECTED WHICH FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTION MANUAL ((B)(4)) CONTAINS THE FOLLOWING DESCRIPTION WHICH RELATE TO THE REPORTED EVENT: "THIS INSTRUCTION MANUAL CONTAINS ESSENTIAL INFORMATION ON USING THIS INSTRUMENT SAFELY AND EFFECTIVELY. BEFORE USE, THOROUGHLY REVIEW THIS MANUAL AND THE MANUALS OF ALL EQUIPMENT WHICH WILL BE USED DURING THE PROCEDURE AND USE THE INSTRUMENTS AS INSTRUCTED. KEEP THIS AND ALL RELATED INSTRUCTION MANUALS IN A SAFE, ACCESSIBLE LOCATION. AFTER USING THIS INSTRUMENT, REPROCESS AND STORE IT ACCORDING TO THE INSTRUCTIONS IN CHAPTER 4, ¿REPROCESSING¿ AND CHAPTER 5, ¿STORAGE¿. IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION CONTROL RISK, CAUSE EQUIPMENT DAMAGE OR REDUCE PERFORMANCE. THE MEDICAL LITERATURE REPORTS INCIDENTS OF PATIENT CROSS CONTAMINATION RESULTING FROM IMPROPER CLEANING OR STERILIZATION. IT IS STRONGLY RECOMMENDED THAT REPROCESSING PERSONNEL HAVE A THOROUGH UNDERSTANDING OF AND FOLLOW ALL NATIONAL AND LOCAL HOSPITAL GUIDELINES AND POLICIES. ALL INDIVIDUALS RESPONSIBLE FOR REPROCESSING SHOULD THOROUGHLY UNDERSTAND: YOUR INSTITUTION¿S REPROCESSING PROCEDURES. OCCUPATIONAL HEALTH AND SAFETY REGULATIONS. NATIONAL AND LOCAL HOSPITAL GUIDELINES AND POLICIES. THE INSTRUCTIONS IN THIS MANUAL. THE MECHANICAL ASPECTS OF ENDOSCOPIC EQUIPMENT. PERTINENT GERMICIDE LABELING". SINCE THERE ARE NO DEFICIENCIES IN THE CARE (CLEANING/STERILIZATION) METHODS DESCRIBED IN THE INSTRUCTION MANUAL, IT IS LIKELY THAT THE USER DID NOT CORRECTLY UNDERSTAND THE CLEANING/DISINFECTING/STERILIZING (CDS) PROCESS AS THE REASON WHY ULTRASONIC CLEANING WAS NOT PERFORMED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE REUSABLE BIOPSY FORCEPS WAS REPROCESSED WITHOUT USING AN ULTRASONIC CLEANER AS REQUIRED. INSTEAD, THE FORCEPS WAS REPORTEDLY IMMERSED IN ENDOFRESH AND THEN IN GLUTARALDEHYDE. IT WAS CONFIRMED THAT THE USER FACILITY KNEW THAT THE DEVICE NEEDED TO BE CLEANED BY IMPLEMENTING ULTRASONIC CLEANING. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE OCCURRED DURING REPROCESSING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM AN OLYMPUS REPRESENTATIVE INDICATING THAT THE CUSTOMER HAD INITIALLY REPORTED THAT THE CUPS OF THE REUSABLE FORCEPS HAD BEEN DIFFICULT TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858052 BIOPSY FORCEPS BIOPSY FORCEPS EOQ AOMORI OLYMPUS CO., LTD. FB-21K-1 14953170029773

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown