BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11070946 · Received December 24, 2020

    Report

    Report Number
    8010047-2020-10960
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    December 1, 2020
    Report Date
    January 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO THE SERVICE DEPARTMENT IN AUSTRALIA. THE EVALUATION OF THE DEVICE BY THE SERVICE DEPARTMENT CONFIRMED FOLLOWING: THE CABLE HAD DENTS AND SCRATCHES. VIDEO CONNECTOR HAS MULTIPLE CRACKS. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE REPORTED EVENT POSSIBLY OCCURRED DUE TO THE DAMAGE OF THE CABLE. THE OPERATION MANUAL OF THE SUBJECT DEVICE HAS ALREADY WARNS FOLLOWING: DO NOT COIL THE CAMERA CABLE WITH A DIAMETER OF LESS THAN 20 CM. THE CAMERA CABLE MAY BE DAMAGED. NEVER EXCESSIVELY PULL THE CAMERA CABLE, BUT STRAIGHTEN IT GRADUALLY WHEN IT IS COILED. THE CAMERA CABLE COULD BE DAMAGED. NEVER EXCESSIVELY BEND, PULL, TWIST, COIL, SQUEEZE, OR CRUSH THE CAMERA CABLE. THE CAMERA CABLE COULD BE DAMAGED. DO NOT USE EXCESSIVE FORCE WHEN WIPING THE EXTERNAL SURFACES OF THE CAMERA CABLE. THE CAMERA CABLE COULD BE DAMAGED. NEVER ATTEMPT TO LIFT THE ENTIRE ASSEMBLY BY THE CAMERA CABLE WHILE THE CAMERA HEAD IS ATTACHED TO THE ENDOSCOPE. THE CAMERA CABLE COULD BE DAMAGED. NEVER USE A CLAMP OR FORCEPS TO ATTACH THE CAMERA CABLE TO ANOTHER OBJECT. THE CAMERA CABLE COULD BE DAMAGED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (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

    DURING THE BIOMEDICAL ENGINEERING INSPECTION, THE ENDOSCOPIC IMAGE WAS FLICKERING WHEN THE CABLE WAS MANIPULATED. THE USER REPLACED THE DEVICE WITH ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536192 4K AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EA

    Patients

    Seq Age Sex Outcome Treatment
    1