BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11114387 · Received January 4, 2021

    Report

    Report Number
    8010047-2021-00823
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Report Date
    February 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS ASSUMED THAT THE ELECTRIC CONTACTS WERE CORRODED BECAUSE REPROCESS WAS INSUFFICIENT OR STORED IN A HUMID ENVIRONMENT. ALSO, IT IS PRESUMED THAT THE UNEXPECTED STRESS ON THE HEAD CAUSED THE WATER LEAKAGE DUE TO THE HANDLING OF THE USER, AND THAT THE IMAGE WAS NO LONGER OUTPUT BECAUSE THE CCD UNIT FAILED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. DO NOT DROP THE CAMERA HEAD OR ALLOW IT TO STRIKE OTHER OBJECTS. STRONG IMPACTS COULD DAMAGE THE ELECTRICAL CIRCUITS INSIDE THE CAMERA HEAD.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OMSC FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED FROM THE USER THAT BEFORE THE PROCEDURE, THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED. THE USER REPLACED THE SUBJECT DEVICE TO ANOTHER DEVICE AND COMPLETED THE PROCEDURE. (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED, AND THE CCD UNIT HEAD HAD FAILURE; THERE WAS LEAKAGE AND THERE IS RUST INSIDE. THE SILICON COVERING THE ELECTRONIC BOARD SHOULD BE CLEAR BUT THIS ONE HAS A DARK COLOR WHICH INDICATES SOME OXIDATION. THE CABLE HAS SOME SIGNS OF OXIDATION TOO AND IT IS A LITTLE BIT TWISTED AND THERE IS SOME STIFFNESS. THE COUPLER IS MISALIGNED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3498 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-12E

    Patients

    Seq Age Sex Outcome Treatment
    1