BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVABLE CAMERA HEAD

    MDR report key: 10566719 · Received September 22, 2020

    Report

    Report Number
    8010047-2020-06726
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Report Date
    November 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FXM
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEGAL MANUFACTURER REVIEWED THE CONTENTS OF THIS COMPLAINT. THE LEGAL MANUFACTURER REPORTED THAT THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. HOWEVER, THE LEGAL MANUFACTURER REPORTED THAT THE PROBABLE CAUSE FOR THE REPORTED EVENT WAS AS FOLLOWS: IT WAS SPECULATED THAT THE IMAGE NOISE OCCURRED BECAUSE THE CABLE WAS SUBJECTED TO UNEXPECTED STRESS DUE TO THE HANDLING OF THE USER AND THE CABLE UNIT FAILED. ALSO, THE BASE PLATE OF THE COUPLER WAS BENT DUE TO UNEXPECTED STRESS APPLIED TO THE HEAD, AND THE CENTER OF THE IMAGE WAS SHIFTED." WHEN CHECKING THE CONTENT OF THE INSTRUCTIONS FOR USE AT THE TIME OF SHIPMENT OF THE PRODUCTS RELATED TO IMPORTANT INFORMATION. PLEASE READ BEFORE USE, IT WAS CONFIRMED THAT THERE WERE THE FOLLOWING ENTRIES: NEVER EXCESSIVELY BEND, PULL, TWIST, COIL, SQUEEZE OR APPLY A CRUSHING FORCE TO THE CAMERA CABLE. THE CAMERA CABLE COULD BECOME DAMAGED. A DHR REVIEW WAS PERFORMED AND CONFIRMED THAT THERE WERE NO ABNORMAL RESULTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE USER¿S COMPLAINT OF ¿BLACK IMAGE¿ WAS CONFIRMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT THE IMAGE IS NOISY AND IT CUTS ON AND OFF DUE TO FAULTY CABLE UNIT. THE COUPLER BASE PLATE IS BENT CAUSING AN OFF-CENTERED IMAGE. THE LISTED PARTS WERE REPLACED. THE DEVICE IS FULLY FUNCTIONAL AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS AN ISSUE WITH THE IMAGE. THE IMAGE DOES NOT APPEAR. THERE IS A BLACK IMAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035665 AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FXM OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7H-1NA-10E

    Patients

    Seq Age Sex Outcome Treatment
    1