BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11277193 · Received February 4, 2021

    Report

    Report Number
    8010047-2021-02219
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE DEVICE INSPECTION RESULTS BY OLYMPUS AUSTRALIA (OAZ), THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING CAUSES. -THE CAMERA CABLE UNIT WAS FAILURE BECAUSE UNEXPECTED STRESS WAS APPLIED TO THE CAMERA CABLE DUE TO THE USER'S HANDLING.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING A LAPAROSCOPIC BOWEL PROCEDURE WITH THE SUBJECT DEVICE AT THE USER FACILITY, THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE WAS DISAPPEARED. THE USER FACILITY REPLACED THE SUBJECT DEVICE TO A SIMILAR DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. OLYMPUS AUSTRALIA (OAZ) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED EVENT WAS DUPLICATED DUE TO THE BREAKAGE OF THE CAMERA CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175276 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD OWN OLYMPUS MEDICAL SYSTEMS CORP. CH-S200-XZ-EA

    Patients

    Seq Age Sex Outcome Treatment
    1