BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS

    MDR report key: 12842531 · Received November 19, 2021

    Report

    Report Number
    8010047-2021-14814
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K962555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS. THE CUPS DID NOT OPEN OR CLOSE WHEN THE SLIDER WAS OPERATED. A BROWN FOREIGN SUBSTANCE HAD ADHERED TO THE LINK MECHANISM OF THE CUPS. AFTER APPLYING THE LUBRICANT, THE CUPS WERE ABLE TO OPERATE SMOOTHLY. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. IT IS PRESUMED THAT THE EVENT WAS CAUSED BY THE COMBINATION OF FOREIGN MATTER ADHESION AND INSUFFICIENT LUBRICATION APPLICATION. IT IS PRESUMED THAT THE ADHESION OF FOREIGN MATTER IS DUE TO INSUFFICIENT CLEANING, OR THAT IT HAS NOT BEEN SUFFICIENTLY CLEANED DUE TO THE PASSAGE OF TIME AFTER USE. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 20-OCT-2021.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE DISTRIBUTOR THAT DURING INSPECTION OF THE SUBJECT DEVICE BEFORE USE, THE CUP DID NOT OPEN AT ALL. THE DEVICE HAS BEEN USED LESS THAN 10 TIMES. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON OCT. 27, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE CUPS DID NOT OPEN OR CLOSE, AND THAT A BROWN FOREIGN SUBSTANCE HAD ADHERED TO THE LINK MECHANISM OF THE DEVICE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743283 BIOPSY FORCEPS BIOPSY FORCEPS EOQ OLYMPUS MEDICAL SYSTEMS CORP. FB-21K-1 K9Y01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown