BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE BIOPSY VALVE (STERILE)

    MDR report key: 11406712 · Received March 3, 2021

    Report

    Report Number
    8010047-2021-03260
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    June 26, 2020
    Report Date
    March 3, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    14953170152433
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, A FOLLOW UP TO THE CUSTOMER WAS PERFORMED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CUSTOMER REPORTED THAT HE DEVICE WAS INSPECTED PRIOR TO USE. NO DAMAGE OR ABNORMALITIES WERE OBSERVED. ALL OF THE TEN VALVES WERE FROM THE SAME LOT NUMBER. THE INSTRUCTIONS FOR USE ARE BEING FOLLOWED. THE ENDOSCOPE BEING USED IS COMPATIBLE WITH THIS DEVICE. THE DEVICE IS BEING STORED IN A SHELF. THE CUSTOMER REPORTED THAT DUE COVID-19 PANDEMIC THE DEVICE WILL NOT BE RETURNED. HOWEVER, THE CUSTOMER DID PROVIDE TWO IMAGES IN WHICH THE BIOPSY VALVE APPEARS BROKEN. IN ADDITION, THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE MANUFACTURING RECORD AS REVIEWED FOR LOT.9ZH, AND IRREGULARITIES OR NON-CONFORMITIES WERE NOT DETECTED. THE LEGAL MANUFACTURER REPORTED THAT SINCE THE BIOPSY VALVE HAS NOT BEEN RETURNED FOR INVESTIGATION A SAMPLE UNIT(LOT.H1101) WAS USED TO CHECK ITS CONNECTION WITH A TEST ENDOSCOPE. THE BIOPSY VALVE CAN BE PROPERLY ATTACHED TO THE ENDOSCOPE WITHOUT CAUSING ANY DAMAGES. THE LM REPORTED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT IS AS FOLLOWS: THE LEGAL MANUFACTURER PRESUMED THAT THE USER WAS NOT FOLLOWING THE HANDLING PROCEDURE DESCRIBED IN THE IFU 7.3 AND THE BIOPSY VALVE BROKE OFF. PLEASE FOLLOW THE INSTRUCTION BELOW TO ATTACH THE BIOPSY VALVE CORRECTLY TO THE ENDOSCOPE. 7.3 ATTACHING THE BIOPSY VALVE TO THE ENDOSCOPE PUT THE BIOPSY VALVE ON THE SUCTION VALVE HOLDER OR THE INSTRUMENT CHANNEL PORT WITH ITS TAB NEAR SIDE IN THE ILLUSTRATED DIRECTION. PUSH THE UPPER PART OF THE BIOPSY VALVE DOWN SLANTINGLY ONTO THE SUCTION VALVE HOLDER OR THE INSTRUMENT CHANNEL PORT UNTIL THE VALVE SNAPS INTO PLACE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SEPARATE PROCEDURES, TEN OR MORE BIOPSY VALVES BROKE WITH NO EXCESSIVE FORCE APPLIED. FOR SOME THE DAMAGE WAS NOTED DURING PREPARATION FOR USE AND OTHERS WERE NOTED DURING PROCEDURE, PRIOR TO THE DOCTOR TAKING THE BIOPSY. NO DEVICE FRAGMENTS FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS 3 OF 11 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303266 SINGLE USE BIOPSY VALVE (STERILE) SINGLE USE BIOPSY VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. MAJ-210 9ZH 14953170152433

    Patients

    Seq Age Sex Outcome Treatment
    1